Behavioral Intervention for Cancer

Overseen By Qian Lu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Life expectancy <6 months, Major depression, Others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether simple activities can boost the quality of life for cancer patients from collectivist cultures, such as Latinos, Asian Americans, and African Americans, and their caregivers. The study focuses on two activities: performing acts of kindness for a caregiver and writing letters of gratitude, aiming to improve feelings of competence and connection. Participants will either track daily activities, perform acts of kindness, or write gratitude notes over four weeks. This Positive Activities Intervention seeks cancer patients diagnosed within the last 1-5 years who self-identify as one of these cultural groups and have a caregiver living with them.

As an unphased trial, this study offers a unique opportunity to contribute to understanding how cultural activities can enhance well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this behavioral intervention is safe for cancer patients and their caregivers?

Research has shown that engaging in positive activities, such as kindness or gratitude, can enhance the quality of life for cancer patients. For instance, one study found that a gratitude program reduced worry and stress in bladder cancer patients. Another study examined the growth of gratitude in patients with advanced cancer and their caregivers, indicating emotional benefits. These activities are generally safe, as they are simple and non-invasive, involving actions like writing letters or performing kind acts. No reports of physical harm or serious side effects have emerged from these activities, making them well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these behavioral interventions for cancer patients because they focus on enhancing mental well-being through simple, meaningful actions. Unlike traditional treatments that may rely on medication or invasive procedures, these interventions empower patients to actively participate in their emotional recovery. The "contribution" arm encourages patients to perform kind acts for their caregivers, fostering a sense of purpose and connection. The "gratitude" arm involves writing letters of appreciation, which can boost positive emotions and strengthen relationships. These non-medical approaches have the potential to improve quality of life and emotional resilience in a unique and accessible way.

What evidence suggests that these positive activities could improve quality of life for cancer patients and their caregivers?

Research has shown that positive activities can benefit cancer patients, particularly those from cultures that emphasize community and family. In this trial, participants will engage in various positive activities. One study found that performing kind acts made patients feel more capable, which aligns with the "Condition I (contribution)" arm, where patients do nice things for their caregivers. Another study discovered that writing letters of gratitude improved mood and reduced stress, similar to the "Condition II (gratitude)" arm, where patients write notes of gratitude. Activities like helping with chores or saying thank you, as seen in the "Condition III (daily activities tracking)" arm, can enhance the quality of life for patients and their caregivers. These activities help patients feel more connected and in control, which is crucial during challenging times. ^{6 7 8 9 10}

Who Is on the Research Team?

Qian Lu, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer patients aged 35-70 from collectivist cultures (Asian American, African American, Latino, European American) within 1-5 years of diagnosis and undergoing treatment. They must have a caregiver of the same ethnicity who lives with them and both must be able to use English and have internet access. Excluded are those with major depression or less than 6 months to live.

Inclusion Criteria

Patients diagnosed with any type of cancer

Caregivers who identify as the same race/ethnicity group as the patient (e.g., European American wife and European American husband, or Asian American wife and Asian American husband would be considered eligible)

Patients between 35-70 years of age

Exclusion Criteria

Caregivers who are unwilling or unable to participate in the study for any reason

You have been diagnosed with severe depression or have high scores on a depression questionnaire.

Patients with a life expectancy less than 6 months in the opinion of the primary physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in one of three conditions: Contribution, Gratitude, or Control, for 4 weeks

4 weeks

No in-person visits, activities performed at home

Follow-up

Participants are monitored for changes in psychological, interpersonal, and physical well-being

4 weeks

Follow-up assessments at the end of the study

What Are the Treatments Tested in This Trial?

Interventions

• Positive Activities Intervention

Trial Overview The study tests two positive activities aimed at improving quality of life for collectivist culture cancer patients and their caregivers: acts of kindness like contributing to household duties, and writing gratitude letters. It assesses if these simple tasks can enhance feelings of competence, autonomy, and connectedness.

How Is the Trial Designed?

Group I: Condition II (gratitude) Experimental Treatment 4 Interventions

Patients write a letter or note of gratitude BIW for 4 weeks to their caregivers who have helped with their treatment or recovery.

Group II: Condition I (contribution) Experimental Treatment 4 Interventions

Patients do 1 nice thing (can be as large or as small as they wish) BIW for 4 weeks for their caregivers while at home.

Group III: Condition III (daily activities tracking) Active Control 4 Interventions

Participants keep track of their daily activities.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A study involving 84 breast cancer patients showed that using a positive behavior management model based on cognitive frameworks significantly increased levels of hope and self-efficacy compared to traditional nursing interventions.

Patients receiving the new intervention also experienced lower anxiety and depression scores, along with improved overall quality of life after the treatment, indicating its effectiveness in supporting psychological well-being during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of positive behavior management in patients after breast cancer surgery. Hao, YJ., Sun, HB., Li, HW., et al.[2020]

Recent studies indicate that while group therapy does not improve survival rates in advanced breast cancer, it can enhance quality of life and alleviate physical symptoms for patients.

Therapies tailored to specific patient needs are more effective than general approaches, highlighting the importance of therapist experience and training in delivering psychosocial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial interventions for cancer patients. Daniels, J., Kissane, DW.[2008]

A Web-based physical activity behavior change program for cancer survivors was found to be feasible, with high satisfaction ratings and a significant number of participants completing the program.

While the increase in physical activity (PA) among participants in the program was not statistically significant, there was a notable trend showing a 42-minute increase in exercise compared to usual care, particularly among those who were initially inactive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Efficacy of an Online Intervention to Increase Physical Activity in Nova Scotian Cancer Survivors: A Randomized Controlled Trial. Forbes, CC., Blanchard, CM., Mummery, WK., et al.[2020]

A systematic review of 20 studies on digital physical activity interventions for breast cancer survivors found that common behavior change techniques (BCTs) like self-monitoring and goal setting were effective, with 60% of studies showing improved physical activity levels.

Despite the effectiveness of these techniques, many potential BCTs were underutilized, suggesting that incorporating a wider variety of strategies could enhance the effectiveness of future digital interventions for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior change techniques in digital physical activity interventions for breast cancer survivors: a systematic review. Cooper, KB., Lapierre, S., Carrera Seoane, M., et al.[2023]

Behavioral interventions, such as breathing exercises that focus on diaphragm use and altering breathing rhythms, can significantly help lung cancer patients manage feelings of breathlessness and improve their quality of life.

Oncology professionals should incorporate these psychosocially oriented strategies alongside medical treatments to effectively address the debilitating symptom of breathlessness in lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions for lung cancer-related breathlessness. Gallo-Silver, L., Pollack, B.[2019]

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]

In a study of 347 cancer patients, reflective processes like affective judgments and perceived capability were found to significantly influence the formation of intentions to engage in physical activity, with 70.9% intending to be active but only 50.4% meeting activity guidelines.

For translating those intentions into action, reflexive processes such as having a strong physical activity identity were crucial, indicating that interventions should focus on enhancing these identities alongside traditional cognitive strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of Physical Activity Participation among Individuals Diagnosed with Cancer: An Application of the Multi-Process Action Control Framework. Tabaczynski, A., Arbour-Nicitopoulos, KP., Rhodes, RE., et al.[2023]

The article emphasizes the need for future behavioral research to improve the adjustment and quality of life for adults diagnosed with cancer, highlighting the importance of psychosocial support in oncology.

It reviews the current state of science in measuring quality of life for cancer patients, suggesting that enhanced behavioral interventions could lead to better psychosocial outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral research to enhance adjustment and quality of life among adults with cancer. Lewis, FM.[2007]

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]

A study involving 98 dyads of breast cancer patients and their caregivers showed that a family-centered positive psychological intervention significantly improved resilience, hope, perceived benefits, and quality of life compared to a control group after 4 weeks.

The intervention's effectiveness was evident at both the end of the treatment and one month later, highlighting its potential as a valuable psychological support strategy for cancer patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of family-centered positive psychological intervention on psychological health and quality of life in patients with breast cancer and their caregivers. Zhang, Y., Tang, R., Bi, L., et al.[2023]

Cancer patients showed the most significant positive change in reflecting on life priorities after diagnosis and treatment, while exercise was the least likely to improve.

Optimism and social support were linked to better physical health behaviors, while only optimism was associated with improvements in psychosocial behaviors, indicating the importance of mental outlook in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of social cognitive processing theory and optimism in positive psychosocial and physical behavior change after cancer diagnosis and treatment. K Harper, FW., Schmidt, JE., Beacham, AO., et al.[2015]

Citations

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Comparing the effectiveness of gratitude intervention and ... Comparing the effectiveness of gratitude intervention and behavioral activation technique in breast cancer patients: a randomized trial.

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Physical Activity and Cancer Care—A Review - PMC The findings from these studies show that physical activity decreases the severity of side effects of cancer treatment, reduces fatigue, improves quality of ...

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Patient outcomes from a physical activity programme for ... A PA programme in primary care can enhance cancer survivors' activity levels and health outcomes, regardless of time post-diagnosis. However, not all survivors ...

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A pilot study of a gratitude journaling intervention to enhance ... Their studies showed that gratitude journaling leads to enhanced mood, reduced psychological distress, and improved outlook, establishing its ...

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The clinical effect of gratitude extension-construction theory ... After applying the gratitude extension construction theory nursing program, the FCR of bladder cancer patients is significantly reduced.

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Positive Activities Intervention to Improve Quality of Life in ... This clinical trial studies the feasibility of two positive activities in improving quality of life in collectivist culture cancer patients and their ...

8. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.991250/full

Gratitude among advanced cancer patients and their ... This study aims to explore whether and how gratitude may originate in patients with advanced cancer and their caregivers undergoing early palliative care (EPC).

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The Effects of Optimism and Gratitude on Physical Activity ... We found that optimism, measured 2 weeks after ACS, was associated with greater physical activity in mean steps/day at 6 months, controlling for ...