Behavioral Activation for Cancer

(BALANCE Trial)

Overseen By Krina C Durica

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-English speakers, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether behavioral activation, a type of therapy, can improve the daily quality of life for people with advanced cancer. It uses a smartphone app and a Fitbit to track activities and encourage meaningful daily routines. The goal is to determine if these changes can enhance mood and overall well-being. Individuals with Stage IV cancer receiving treatment at a UPMC Hillman Cancer Center clinic, who regularly use a smartphone, might be suitable for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance quality of life for others.

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 prior data suggests that behavioral activation is safe for patients with advanced cancer?

Research has shown that behavioral activation is generally safe. In one study, a few participants experienced more suicidal thoughts, but this occurred less frequently in the group using behavioral activation (3.7%) compared to another group receiving different care (7.4%). This suggests that behavioral activation might be easier to handle than other treatments. No major physical side effects were reported. Overall, the treatment appears well-tolerated and safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Behavioral Activation for cancer patients because it focuses on enhancing quality of life through daily activity tracking and behavior change, using a smartphone app. Unlike traditional cancer therapies that primarily target the disease itself, this method empowers patients to actively engage in their own well-being by identifying and increasing activities that boost their daily life satisfaction. The use of technology to support behavior change is a novel approach, providing personalized reminders and feedback to help patients make meaningful lifestyle adjustments that could improve their overall mental and emotional health during treatment.

What evidence suggests that behavioral activation might be an effective treatment for advanced cancer?

Research has shown that behavioral activation, which participants in this trial will engage in through activity tracking via a smartphone app, can improve the quality of life for cancer patients. Studies have found it effective in reducing symptoms of depression and anxiety. In one study, patients reported feeling better and less stressed after attending behavioral activation sessions. Another study showed it significantly improved emotional well-being compared to regular treatment. This approach focuses on involving patients in meaningful activities, enhancing their overall quality of life. ^{2 6 7 8 9}

Who Is on the Research Team?

Carissa A Low, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for patients with advanced cancer who are interested in improving their daily quality of life. Participants need to be willing to use a smartphone and wear a Fitbit tracker, complete questionnaires, and engage in personalized activities as guided by the study.

Inclusion Criteria

I have Stage IV cancer and am getting treatment at a UPMC Hillman Cancer Center.

Owns and uses a smartphone capable of running study applications

Exclusion Criteria

I cannot read, write, or speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Data Collection

Participants complete baseline questionnaires and are oriented to the study procedures, including installing the BALANCE app and wearing a Fitbit.

4 weeks

1 visit (in-person or online)

Mid-Study Data Review

Participants review their data with a team member and select activities to increase for the next phase.

1 week

1 visit (in-person or online)

Data-Based Intervention

Participants engage in behavior change activities, receive daily reminders, and complete surveys.

4 weeks

Follow-up

Participants complete a semi-structured interview and end-of-study questionnaire.

1 week

1 visit (in-person or online)

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation

Trial Overview The study tests whether behavioral activation can enhance day-to-day living for those with advanced cancer. It involves tracking activity via Fitbit, completing surveys on mood and quality of life, and adapting daily behaviors through guidance over an 8-week period.

How Is the Trial Designed?

Group I: Activity tracking via smartphone app Experimental Treatment 1 Intervention

Participants will rate their day and indicate activities they did that day via the smartphone once each evening for the first four weeks. After four weeks, they will complete a mid-study data review session with a study team member about the activities, behaviors, and experiences they believe are most strongly related to their day-to-day quality of life. For the last 4 weeks of the study, they will select at least 4 behaviors or activities to increase. Participants will fill out morning surveys to plan an activity, receive daily reminders through the BALANCE app to support behavior change, and complete evening surveys to report daily quality of life and indicate completed activities.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

Behavioral activation (BA) significantly improves the quality of life and emotional well-being of lung and breast cancer patients undergoing chemotherapy, as shown in a study with 50 lung cancer patients and 33 breast cancer patients in the experimental group.

The intervention helps patients maintain rewarding activities, which can enhance their social and role functioning while reducing avoidance behaviors, demonstrating BA as a practical approach during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Behavioral Activation on the Quality of Life and Emotional State of Lung Cancer and Breast Cancer Patients During Chemotherapy Treatment. Fernández-Rodríguez, C., Villoria-Fernández, E., Fernández-García, P., et al.[2020]

Behavioral interventions play a crucial role in managing side effects of cancer treatments, particularly in reducing nausea and vomiting caused by chemotherapy, which is a primary focus of current research.

These interventions are also being applied to alleviate other distressing symptoms such as anxiety and pain in both adult and pediatric cancer patients, highlighting their importance in comprehensive cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in behavioral intervention in comprehensive cancer treatment. Redd, WH.[2019]

This study is the first randomized controlled trial examining the effectiveness of a behavioral activation (BA) program specifically for treating depression in patients with advanced cancer, involving 38 participants across three sites in Japan.

The primary outcome measure is the Beck Depression Inventory-II (BDI-II) score, and the results are expected to provide evidence for BA as a feasible and acceptable intervention to improve mood and quality of life in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation for depression in patients with advanced cancer: study protocol for a multicenter randomized controlled trial. Hirayama, T., Ogawa, Y., Ogawa, A., et al.[2023]

A retrospective review of 10 cancer patients undergoing behavioral activation therapy (BAT) showed a high completion rate (90%) and significant improvements in depression and anxiety scores, indicating BAT's potential effectiveness in this population.

Patients reported substantial reductions in depression (PHQ-9 scores decreased from 14.4 to 5.1) and anxiety (GAD-7 scores decreased from 11.9 to 4.7) after completing the program, suggesting that BAT can be a valuable non-pharmacological treatment option for managing mental health in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation therapy for depression and anxiety in cancer patients: a case series study. Hirayama, T., Ogawa, Y., Yanai, Y., et al.[2022]

Both Behavioral Activation (BA) and Acceptance and Commitment Therapy (ACT) are effective treatments for emotional problems in cancer survivors, as shown in a study of 52 patients, where both therapies outperformed a waiting list control group.

ACT was found to be more effective than BA in reducing social impairment and avoidance/rumination, indicating that these mechanisms play a key role in improving emotional well-being among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating anxiety and depression of cancer survivors: Behavioral activation versus acceptance and commitment therapy. González-Fernández, S., Fernández-Rodríguez, C., Paz-Caballero, MD., et al.[2018]

Behavioral science is crucial in cancer control, influencing all stages from prevention to terminal care, and can significantly enhance health outcomes through effective strategies like smoking cessation and cancer screening.

Implementing behavioral strategies could lead to substantial benefits, such as 7.2 million fewer smokers, 45,000 additional 5-year cancer survivors annually, and improved quality of life for 150,000 patients suffering from treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral science in translational research and cancer control. Morrow, GR., Bellg, AJ.[2019]

Behavioral science is increasingly recognized as a crucial component in cancer control, contributing to prevention, early detection, and survivorship strategies.

The collaboration between behavioral and biomedical sciences is expected to enhance efforts in reducing cancer incidence and improving patient outcomes, highlighting the importance of interdisciplinary research in the fight against cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral oncology and the war on cancer: partnering with biomedicine. Stefanek, ME., Andrykowski, MA., Lerman, C., et al.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10345282/

Feasibility and Preliminary Effectiveness of Behavioral ... This study aimed at examining the feasibility and preliminary effectiveness of BA for patients with cancer and depression in Japan.

2. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-023-10926-y

Behavioral activation for depression in patients with advanced ... The preliminary study showed high rates of treatment completion and remission of depressive symptoms, regardless of the stage of cancer, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748924002967

Effects of behavioural activation on psychological distress ... (2023), behavioural activation was found to be more effective than treatment-as-usual in relieving anxiety and depression in adults with cancer. Meanwhile, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06348940

Study Details | NCT06348940 | Effects of Behavioral ... This study aims to demonstrate the significant efficacy of behavioral activation in improving negative emotions, somatic symptoms, quality of life, and clinical ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37457329/

Feasibility and Preliminary Effectiveness of Behavioral ... This study aimed at examining the feasibility and preliminary effectiveness of BA for patients with cancer and depression in Japan.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11475026/

Impacts and Pathways of Behavioral Activation on ... The objective of this study is to investigate the efficacy of behavioral activation (BA), a novel psychological intervention, in ameliorating psychological ...

7. e-century.us e-century.us/files/ajcr/15/3/ajcr0162071.pdf

The impact of behavioral activation on depressive ... Consistent with our study, a randomized con- trolled trial assessed the effectiveness of BA in cancer outpatients with comorbid depressive.

8. cambridge.org cambridge.org/core/journals/bjpsych-open/article/efficacy-and-safety-of-behavioural-activation-on-depression-in-people-with-cooccurring-noncommunicable-diseases-systematic-review-and-metaanalysis/1F613DB72F1BF0F09C8BE0985DBCCB87

Efficacy and safety of behavioural activation on depression ... Increased suicidal ideation affected 3.7% of the behavioural activation group and 7.4% of the enhanced usual care group. Unexpected physical ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789419300061

Acceptability and Efficacy of Group Behavioral Activation ... While the efficacy of behavioral activation (BA) has been tested in clinical trials with substance users, outcomes have not yet been quantitatively synthesized.