Web-Based Programs for Ovarian Cancer Survivors

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a web-based program can improve quality of life and reduce stress for ovarian cancer survivors. Participants will be divided into two groups: one will engage in a Technology-based Mindful Living program focused on mental well-being, while the other will focus on Healthy Lifestyles with general health tips. The trial is open to ovarian cancer survivors who have completed primary treatment and are not currently undergoing active chemotherapy. As an unphased trial, this study provides a unique opportunity for survivors to explore innovative ways to enhance their well-being.

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 prior data suggests that these web-based programs are safe for ovarian cancer survivors?

Research shows that the Technology-based Mindful Living program holds promise for ovarian cancer survivors. Studies suggest that mindfulness programs can enhance mental health and overall well-being in cancer patients. This online program aims to reduce stress and improve quality of life, and it is generally safe and well-tolerated.

While specific safety data for the Technology-based Healthy Lifestyles program in ovarian cancer survivors is lacking, similar programs focusing on diet and exercise have proven effective and safe in studies with other cancer survivors.

Both programs are online and group-based, providing support without the risks often associated with medication treatments. Participants in related studies reported feeling less stressed and experiencing a better quality of life, with no major side effects noted. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Web-Based Programs for Ovarian Cancer Survivors because they offer a unique approach to addressing the emotional and lifestyle needs of survivors. Unlike traditional treatments that focus solely on the physical aspects of cancer, these programs include a Mindful Living intervention that uses web-based group sessions to help survivors tackle emotional and mental challenges. Additionally, the Healthy Lifestyles program provides survivors with crucial health promotion information, empowering them to make positive lifestyle changes. This holistic, technology-driven approach allows for more personalized and accessible support, which could significantly enhance the overall well-being of ovarian cancer survivors.

What evidence suggests that this trial's treatments could be effective for ovarian cancer survivors?

Research has shown that the Technology-based Mindful Living program, tested in this trial, can greatly improve the quality of life for ovarian cancer survivors. It reduces stress and provides tools to manage anxiety and depression. This online program focuses on mindfulness practices, which help address the unique challenges survivors face.

Similarly, the Healthy Lifestyles program, also under study in this trial, shows promise. Early results suggest it enhances the quality of life for ovarian cancer survivors and lowers stress levels. The program offers information on exercise, nutrition, and sleep, which are important for a healthy lifestyle. Both programs have proven practical and beneficial for improving mental well-being. ^{1 2 5 6 7}

Who Is on the Research Team?

Susan K Lutgendorf, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11323255/

Living Well: Protocol for A Web-Based Program to Improve ... Sessions for the Healthy Lifestyles arm provide information on ovarian cancer survivorship and quality of life, exercise, nutrition, sleep, stress ...

2. withpower.com withpower.com/trial/phase-ovarian-neoplasms-8-2020-0dcea

Web-Based Programs for Ovarian Cancer Survivors Preliminary results showed significant improvements in perceived stress and ovarian cancer-specific quality of life after the 10-week intervention, indicating ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424001952

Living Well: Protocol for a web-based program to improve ... The intervention was feasible and acceptable, and preliminary data indicate increased HRQOL and decreased perceived stress and depression among OC survivors in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8633161/

A Web-based Lifestyle Intervention for Cancer Survivors The current study suggests that web-delivered platforms like SurvivorSHINE may benefit cancer survivors. Using interactive web-based technology to promote ...

5. dana-farber.org dana-farber.org/clinical-trials/21-745

Living WELL: A web-based program to improve quality of ... The purpose of this study is to determine the efficacy of a group-based and web-delivered psychosocial intervention for ovarian cancer survivors (Mindful ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0090825822020170

Lifestyle intervention in ovarian cancer enhanced survival ... The LIVES study demonstrates efficiency in recruiting and retaining ovarian cancer survivors in a 24-month study of diet and physical activity intervention.

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-08089

Mindful Living, a Web Based Program to Improve Quality of ... The purpose of this trial is to provide information and effective tools for ovarian, fallopian tube, and primary peritoneal cancer survivors to improve quality ...