Resilience-Building Intervention for Cancer

Overseen By Li-Ting Longcoy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Cognitive impairment

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

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the web-based resilience-building treatment for cancer patients?

Research shows that web-based interventions, like cognitive behavior therapy (CBT), can help reduce distress and improve quality of life for cancer patients. Additionally, internet interventions are seen as promising tools to address mental health needs in cancer care. ^{1 2 3 4 5}

Is the resilience-building intervention for cancer safe for humans?

The pilot testing of an app-based stress management intervention for cancer survivors showed it was well-received and safe, with participants reporting decreased stress and anxiety. This suggests that similar web-based resilience-building interventions are generally safe for humans. ^{6 7 8 9 10}

How is the web-based resilience-building treatment for cancer unique?

This web-based resilience-building treatment is unique because it provides psychological support through the internet, allowing patients to access help independently of time and place, which is particularly beneficial for those who may not have easy access to face-to-face support. It focuses on reducing psychological distress and improving quality of life, similar to other internet-based interventions, but emphasizes building resilience specifically for cancer patients. ^{3 4 6 11 12}

What is the purpose of this trial?

The aims of this study are to (1) identify the advance care planning deliberation process among 20 dyads of patients with advanced cancer and family caregivers and (2) conduct usability testing among 9 dyads to refine the content and design of the web-based resilience-building intervention.

Eligibility Criteria

This trial is for adults over 18 with advanced stage 3 or 4 cancer who have completed an advance directive, like a living will. They must be able to understand English and have internet access. Their family caregiver, also over 18 and English-speaking, should be the designated health care surrogate willing to participate.

Inclusion Criteria

Patients able to read and respond to questions in English with minimal assistance from family caregivers for interpretation

Patients who have previously completed an advance directive such as a living will

Patients with a family caregiver who serves as a surrogate in the advance directive and is willing to participate in the study

Exclusion Criteria

Patients with cognitive impairment per a Short Portable Mental Status Questionnaire score < 8

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a web-based resilience-building intervention consisting of assessments and 6 weekly modules

6 weeks

Usability Testing

Qualitative feedback is collected from participants about the impressions of the website prototype

Immediately at the end of the usability testing

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Web-based resilience-building intervention

Trial Overview The study tests a web-based program designed to help patients with advanced cancer and their caregivers discuss future medical care preferences. It involves identifying how they deliberate on advance care planning and refining the intervention based on feedback from participants.

Participant Groups

Group I: Web-based resilience-building Experimental Treatment 1 Intervention

The web-based resilience-building intervention will be implemented on a website and consist of (1) assessments to help participants (a) understand their coping strategies and (b) appraise their beliefs, values, and goals about advance care planning and (2) 6 weekly modules.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

In a study involving 356 cancer patients, the telephone caseworker (TCW) model showed a significant improvement in physical functioning at 3 months compared to usual care, suggesting potential benefits of this intervention.

Participants in the TCW model reported better communication with their healthcare team and were more likely to have their needs addressed, indicating that this model may help in managing psychosocial needs, although no overall intervention effect was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Girgis, A., Breen, S., Stacey, F., et al.[2022]

Internet interventions can effectively address the mental health needs of cancer patients and survivors, helping to fill significant treatment gaps in psychosocial oncology.

Despite the potential, there are currently few rigorous studies on online mental health interventions specifically for cancer patients, highlighting the need for more research and the establishment of best practices in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet interventions for improving psychological well-being in psycho-oncology: review and recommendations. Leykin, Y., Thekdi, SM., Shumay, DM., et al.[2022]

The Make It Training optimized is a web-based psycho-oncological intervention developed through a thorough six-step process, including patient needs assessment and prototype testing, aimed at supporting cancer-affected patients.

This intervention consists of 16 interactive self-guided modules that can be completed over 16 weeks, and it is currently being evaluated in a multicenter randomized controlled trial to assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and skills-based eHealth intervention to reduce distress in cancer-affected patients in the Reduct trial: Intervention protocol of the make it training optimized. Heinen, J., Bäuerle, A., Schug, C., et al.[2022]

A self-guided Web-based cognitive behaviour therapy (CBT) intervention, called Cancer Coping Online (CCO), significantly improved physical functioning and reduced cancer-related distress among 60 individuals recently diagnosed with cancer over a 6-week period.

Participants in the CCO group reported better health-related quality of life (HRQOL) and lower anxious preoccupation compared to those in the attention control group, indicating the potential efficacy of this online intervention for supporting cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of a self-guided Web-based CBT intervention for reducing cancer-distress: a randomised controlled trial. Beatty, L., Koczwara, B., Wade, T.[2019]

This rapid review identified 10 studies that highlight the importance of using an iterative, co-design approach when developing web-based interventions for people affected by cancer, ensuring that user needs and preferences are prioritized.

The findings emphasize that web-based resources should be designed based on user experiences and current guidelines, and should undergo usability and acceptability testing to ensure they effectively meet the needs of their intended audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid systematic review on developing web-based interventions to support people affected by cancer. Cooke, S., Nelson, D., Green, H., et al.[2023]

The Stress Proffen app-based intervention for cancer survivors showed significant reductions in stress, anxiety, and self-regulatory fatigue, along with improvements in health-related quality of life, based on a pilot study with 25 participants.

Participants found the app to be a valuable and accessible tool for stress management, with 67% completing at least 7 out of 10 modules, indicating good engagement and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot testing an app-based stress management intervention for cancer survivors. Børøsund, E., Varsi, C., Clark, MM., et al.[2022]

A web-based self-report assessment and educational intervention significantly reduced symptom distress in cancer patients, with the intervention group showing a decrease in distress scores compared to the control group (1.27 vs -0.04).

The intervention was particularly beneficial for participants over 50 years old, suggesting that age may influence the effectiveness of web-based self-care support during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic self-report assessment for cancer and self-care support: results of a multicenter randomized trial. Berry, DL., Hong, F., Halpenny, B., et al.[2021]

The development of the PRO-CTCAE, a patient-reported outcome measurement system, aims to improve the detection of symptomatic adverse events (AEs) in cancer clinical trials by allowing patients to self-report their experiences, addressing the limitations of the traditional investigator-reported CTCAE.

A systematic evaluation identified 78 AEs suitable for patient self-reporting, resulting in a library of 124 items that demonstrated strong measurement properties, including validity and reliability, in a diverse group of cancer patients, enhancing the accuracy and patient-centeredness of AE reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Basch, E., Reeve, BB., Mitchell, SA., et al.[2022]

A study involving 14 clinicians revealed that motivations for reporting serious oncology-associated adverse drug reactions included scientific curiosity and public health concerns, but feedback from pharmaceutical manufacturers was predominantly negative.

The research highlights the need for improved pharmacovigilance mechanisms, such as big data and registries, to enhance the reporting and documentation of adverse drug events, addressing barriers like complacency and indifference among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. Bennett, CL., Schooley, B., Taylor, MA., et al.[2020]

A survey of 727 stakeholders in cancer clinical research revealed that 93% believe patient-reported outcomes (PROs) for adverse events would enhance understanding of patient experiences during treatment.

The majority of respondents (88%) felt that using the PRO-CTCAE would improve the quality and efficiency of symptom data collection, indicating strong support for its implementation in clinical trials to inform treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Bruner, DW., Hanisch, LJ., Reeve, BB., et al.[2022]

A systematic review of 35 studies, including 30 randomized controlled trials, found that internet-based support interventions can positively impact the quality of life and physical health of breast cancer patients.

However, the effectiveness of these interventions in reducing psychological distress, anxiety, and depression was inconsistent, highlighting the need for more rigorous research to better understand their overall impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based support interventions on patients with breast cancer: a systematic review and narrative synthesis. Huang, Y., Li, Q., Zhou, F., et al.[2022]

The STREAM intervention, a web-based stress management program for newly diagnosed cancer patients, aims to improve quality of life and reduce anxiety and depression through eight modules with minimal psychologist contact, involving 120 participants in a controlled trial.

This study is significant as it explores the feasibility and efficacy of online psychological support for cancer patients, potentially offering a cost-effective and accessible alternative to traditional face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study. Grossert, A., Urech, C., Alder, J., et al.[2018]

References

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

Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Internet interventions for improving psychological well-being in psycho-oncology: review and recommendations. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness and skills-based eHealth intervention to reduce distress in cancer-affected patients in the Reduct trial: Intervention protocol of the make it training optimized. [2022]

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

Evaluating the efficacy of a self-guided Web-based CBT intervention for reducing cancer-distress: a randomised controlled trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Rapid systematic review on developing web-based interventions to support people affected by cancer. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Pilot testing an app-based stress management intervention for cancer survivors. [2022]

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

Electronic self-report assessment for cancer and self-care support: results of a multicenter randomized trial. [2021]

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

Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). [2022]

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

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). [2022]

11. England pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based support interventions on patients with breast cancer: a systematic review and narrative synthesis. [2022]

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

Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study. [2018]