Web-Based Programs for Ovarian Cancer Survivors

Recruiting at 4 trial locations

Overseen By Debra J O'Connell-Moore, MBA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Susan Lutgendorf

Disqualifiers: Non-epithelial ovarian cancer, Psychosis, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

326 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the efficacy of a group-based and web-delivered psychosocial intervention for ovarian cancer survivors (Mindful Living \[ML\]) compared to a health promotion condition (Healthy Lifestyles \[HL\]) in increasing health related quality of life (HRQOL) and decreasing perceived stress (primary aim), and decreasing anxiety, depressive mood, and fatigue (secondary aims) across a 12-month period.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you can continue participating even if you are on maintenance therapy or if you recur during the trial and need chemotherapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can continue if they are on maintenance therapy or if they recur during the study, even while taking chemotherapy.

What data supports the idea that Web-Based Programs for Ovarian Cancer Survivors is an effective treatment?

The available research shows that Web-Based Programs for Ovarian Cancer Survivors, which include mindfulness-based interventions, are effective in improving the quality of life and reducing anxiety and depression among cancer survivors. One study specifically tailored an Internet-based group intervention for ovarian cancer survivors, making it easier for them to participate from home. This is important because attending in-person sessions can be challenging due to physical limitations. Additionally, mindfulness-based interventions have been shown to help with common cancer-related issues like fear of recurrence, stress, and fatigue. Overall, these programs offer a promising alternative to traditional face-to-face therapies, especially for those who have difficulty accessing in-person support. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Technology-based Healthy Lifestyles program, Healthy Lifestyles, Mindful Living, Technology-based Mindful Living program, Mindful Living, Healthy Lifestyles for ovarian cancer survivors?

Research shows that mindfulness-based interventions, which are part of the treatment, can help reduce anxiety, depression, and improve quality of life for cancer patients and survivors. These interventions have been adapted for online use, making them accessible for ovarian cancer survivors who may have difficulty attending in-person sessions. ^{1 2 3 4 5}

What safety data exists for web-based programs for ovarian cancer survivors?

The provided research does not directly address safety data for web-based programs specifically for ovarian cancer survivors. However, the LIVES study, a large behavior-based lifestyle intervention trial for ovarian cancer survivors, involves a telephone-based lifestyle intervention with health coaches and uses a multi-modal platform for information delivery. This suggests a structured and monitored approach, which may imply considerations for safety, though specific safety data is not detailed in the abstracts. ^{1 6 7 8 9}

Is the web-based program for ovarian cancer survivors safe?

The studies reviewed do not specifically address safety concerns for the web-based programs, but similar lifestyle and mindfulness-based interventions have been used in other cancer survivors without reported safety issues. ^{1 6 7 8 9}

Is the Technology-based Mindful Living program a promising treatment for ovarian cancer survivors?

Yes, the Technology-based Mindful Living program is promising for ovarian cancer survivors. It uses the internet to help survivors manage stress and improve their lifestyle from home, which is helpful for those who can't easily attend in-person sessions. This approach can improve their quality of life by addressing their social and psychological needs. ^{2 6 10 11 12}

How is the Technology-based Mindful Living program different from other treatments for ovarian cancer survivors?

The Technology-based Mindful Living program is unique because it is an internet-based treatment that combines elements of stress management, mindfulness, and acceptance therapy to support ovarian cancer survivors. This approach is tailored to meet the specific needs of survivors who may have difficulty attending in-person sessions, offering a convenient and accessible way to improve their well-being from home. ^{2 6 10 11 12}

Research Team

Susan K Lutgendorf, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for English-speaking ovarian cancer survivors, aged 18 or older, who have completed primary treatment within the last 5 years. Participants can be undergoing maintenance therapy but must not have had more than one recurrence of cancer. They should be willing to participate in a web-based program and follow-up for a year.

Inclusion Criteria

I am a woman currently on therapy after my initial or first recurrence cancer treatment.

Survivors receiving active treatment for another cancer may be eligible when their treatment is completed

Survivors must be willing to be randomized and followed for 12 months

Exclusion Criteria

People who are feeling very sad or down right now with a score of 24 or higher on a depression test.

I am currently undergoing my first round of chemotherapy.

I have a history of depression but am not currently depressed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Introductory Meeting

Participants take part in an introductory online meeting to familiarize themselves with the study procedures

1 session

1 visit (virtual)

Intervention

Participants engage in a 10-week group-based and web-delivered psychosocial intervention, either Mindful Living or Healthy Lifestyles

10 weeks

10 visits (virtual)

Follow-up

Participants are monitored for changes in health-related quality of life, stress, anxiety, depressive mood, and fatigue

12 months

2 follow-up visits (virtual) at 4.5 and 9 months

Treatment Details

Interventions

• Technology-based Healthy Lifestyles program
• Technology-based Mindful Living program

Trial Overview The study tests two web-delivered programs: Mindful Living (ML) aims to improve quality of life and reduce stress, while Healthy Lifestyles (HL) promotes health education. The effectiveness will be measured over a year by looking at participants' quality of life, stress levels, mood changes, anxiety, and fatigue.

Participant Groups

Group I: Mindful Living (ML) Experimental Treatment 1 Intervention

Mindful Living Intervention A 10-week group-based and web-delivered psychosocial intervention targeting key concerns of ovarian cancer survivors.

Group II: Healthy Lifestyles (HL) Active Control 1 Intervention

Healthy Lifestyle Intervention A 10-week group-based and web-delivered intervention providing information on health promotion for ovarian cancer survivors.

Who Is Running the Clinical Trial?

Susan Lutgendorf

Lead Sponsor

Trials

2

Recruited

940+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Findings from Research

eHealth mindfulness-based interventions (eHealth-MBIs) showed small but significant improvements in anxiety and depression among cancer patients and survivors, with standardized mean differences of -0.28 and -0.24, respectively, based on a review of 18 studies.

These interventions also positively impacted quality of life and mindfulness in the short term, suggesting they are a cost-effective and accessible option for supporting mental health in cancer care, although the overall quality of evidence was rated low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth mindfulness-based interventions on cancer-related symptoms among cancer patients and survivors: A systematic review and meta-analysis. Fung, JYT., Lim, H., Vongsirimas, N., et al.[2022]

An Internet-based group intervention for ovarian cancer survivors was found to be highly usable and acceptable, with participants easily navigating the platform and engaging in the program.

Preliminary results showed significant improvements in perceived stress and ovarian cancer-specific quality of life after the 10-week intervention, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Group Intervention for Ovarian Cancer Survivors: Feasibility and Preliminary Results. Kinner, EM., Armer, JS., McGregor, BA., et al.[2020]

Mindfulness-based interventions (MBIs), particularly mindfulness-based cancer recovery (MBCR), have been shown to improve psychological and biological outcomes in cancer survivors, including reductions in depression, anxiety, and improvements in cortisol levels and telomere length.

Recent clinical trials indicate that MBCR is effective compared to other therapies, such as supportive-expressive therapy and cognitive behavioral therapy for insomnia, highlighting its potential as a valuable treatment option for cancer-related distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for coping with cancer. Carlson, LE.[2018]

Mindfulness-based cognitive therapy (MBCT) significantly reduced fear of cancer recurrence (FCR) in ovarian cancer survivors after an 8-week program, with participants showing a decrease in FCR scores from an average of 71.03 to 63.00.

While anxiety levels also decreased during the study, the reduction in FCR was not maintained at the 6-month follow-up, indicating the need for further research to confirm the long-term efficacy of MBCT for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for Fear of Recurrence in Ovarian Cancer Survivors (FROCS): a single-arm, open-label, pilot study. Cohen, PA., Musiello, T., Jeffares, S., et al.[2022]

Mindfulness-based interventions significantly reduce anxiety, depression, fatigue, and stress while improving quality of life and posttraumatic growth in adult cancer patients and survivors, based on a review of 29 randomized controlled trials involving 3476 participants.

Mindfulness-based art therapy (MBAT) showed the strongest effects on reducing anxiety and depression, indicating its potential as an effective complementary treatment for managing cancer-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness-based interventions among cancer patients and survivors: a systematic review and meta-analysis. Xunlin, NG., Lau, Y., Klainin-Yobas, P.[2021]

The Mindfulness in Motion + Diet (MIM+D) intervention was found to be feasible for endometrial cancer survivors, with a high completion rate of 76% and 90% attendance at sessions, indicating good acceptability among participants.

While the overall program did not significantly improve outcomes for all participants, those who completed the program showed meaningful improvements in mindfulness and moderate changes in diet, physical activity, and health-related quality of life, suggesting potential benefits for adherent individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindfulness-Based Lifestyle Intervention for Obese, Inactive Endometrial Cancer Survivors: A Feasibility Study. Lucas, AR., Focht, BC., Cohn, DE., et al.[2023]

Breast cancer survivors using a health and wellness coaching app showed significant weight loss and a greater reduction in body mass index compared to those using a self-guided toolkit, indicating the app's effectiveness in promoting healthier lifestyles.

The app users also reported improvements in physical activity and dietary patterns, suggesting that access to live coaching can enhance adherence to wellness plans, although long-term app usage declined after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Mobile Health Intervention to Improve Wellness Outcomes for Breast Cancer Survivors. Cairo, J., Williams, L., Bray, L., et al.[2022]

An 8-week behavioral lifestyle intervention for endometrial cancer survivors led to significant improvements in dietary habits compared to usual care, with a notable increase in the Alternative Healthy Eating Index score.

Participants in the intervention group reported improved quality of life at the 24-week follow-up, with no adverse events related to the intervention, suggesting it is a safe and beneficial approach for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet, physical activity, and health-related outcomes of endometrial cancer survivors in a behavioral lifestyle program: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomized controlled pilot trial. Koutoukidis, DA., Beeken, RJ., Manchanda, R., et al.[2021]

The LIVES NRG 0225 study is a large randomized controlled trial involving women with stage II-IV ovarian cancer, aiming to determine if a 24-month lifestyle intervention focused on a high vegetable and fiber, low-fat diet and increased physical activity can improve progression-free survival (PFS) after treatment.

This study will also assess quality of life (QoL) and gastrointestinal health, using a comprehensive approach that includes dietary adherence monitoring and mechanistic biomarker analysis, making it the largest behavior-based lifestyle intervention trial for ovarian cancer survivors to date.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study. Thomson, CA., Crane, TE., Miller, A., et al.[2023]

In a pilot study involving 35 cancer survivors over 2 weeks, participants showed significant engagement with the SurvivorSHINE lifestyle intervention website, averaging 3.2 log-ins and 94 minutes spent on the site, indicating a strong interest in diet and exercise resources.

Increased time spent on the website was positively correlated with improvements in physical activity levels, suggesting that while website use did not directly impact dietary knowledge or weight, it may enhance physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Lifestyle Interventions for Survivors of Cancer: Usability Study. Williams, V., Brown, N., Moore, JX., et al.[2022]

Lifestyle interventions can significantly improve physical functioning and reduce fatigue in endometrial cancer survivors, based on a review of eight studies involving 413 patients.

While these interventions showed benefits like weight loss and increased physical activity, they did not lead to improvements in overall quality of life as measured in the meta-analysis, indicating that more research is needed to fully understand their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of lifestyle interventions on the quality of life of gynaecological cancer survivors: A systematic review and meta-analysis. Smits, A., Lopes, A., Das, N., et al.[2022]

Ovarian cancer survivors face significant psychosocial challenges, including high levels of distress, depression, and anxiety, particularly among younger survivors under 45, who report lower quality of life compared to older survivors.

Access to social support and relational support is crucial for these survivors, as feelings of isolation are common, and addressing their psychosocial needs can lead to improvements in quality of life and personal relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A literature review of the social and psychological needs of ovarian cancer survivors. Roland, KB., Rodriguez, JL., Patterson, JR., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth mindfulness-based interventions on cancer-related symptoms among cancer patients and survivors: A systematic review and meta-analysis. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Internet-Based Group Intervention for Ovarian Cancer Survivors: Feasibility and Preliminary Results. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for coping with cancer. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for Fear of Recurrence in Ovarian Cancer Survivors (FROCS): a single-arm, open-label, pilot study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness-based interventions among cancer patients and survivors: a systematic review and meta-analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A Mindfulness-Based Lifestyle Intervention for Obese, Inactive Endometrial Cancer Survivors: A Feasibility Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Mobile Health Intervention to Improve Wellness Outcomes for Breast Cancer Survivors. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Diet, physical activity, and health-related outcomes of endometrial cancer survivors in a behavioral lifestyle program: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomized controlled pilot trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Lifestyle Interventions for Survivors of Cancer: Usability Study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The effect of lifestyle interventions on the quality of life of gynaecological cancer survivors: A systematic review and meta-analysis. [2022]

12. England pubmed.ncbi.nlm.nih.gov

A literature review of the social and psychological needs of ovarian cancer survivors. [2022]