Group Interventions for Breast Cancer Survivors

Not currently recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Hormone therapy

Disqualifiers: Metastatic disease, Psychiatric disturbance, 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 aims to assist breast cancer survivors by comparing two types of support groups: a Meaning-Centered Group and a Discussion Group. The Meaning-Centered Group helps participants find purpose and meaning in their lives after cancer, while the Discussion Group provides a supportive space to share experiences with fellow survivors. The study also evaluates the effectiveness of running these groups virtually using phones and computers. Individuals who have completed treatment for non-metastatic breast cancer (cancer that hasn't spread to other parts of the body) may be suitable candidates, particularly if they have access to a phone and internet. As an unphased trial, this study offers a unique opportunity to explore personal growth and connection in a supportive environment.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. However, if you are taking medication for mood, anxiety, depression, or sleep, your dosage and use should be stable and consistent.

What prior data suggests that these group interventions are safe for breast cancer survivors?

Research has shown that the Meaning-Centered Group (MCG) for breast cancer survivors is safe. Studies have found that participants in these groups feel better emotionally, experience less trauma, and have improved mental well-being. No reports of serious side effects suggest that participants handle the sessions well.

The Discussion Group (DG) functions more like a support group. These groups are generally safe, focusing on sharing experiences and mutual support. Like the MCG, no major negative effects have been linked to participation.

Overall, both group activities appear to be safe options for breast cancer survivors seeking emotional support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS) because it focuses on enhancing the sense of meaning and purpose in survivors' lives, which is different from standard support groups that typically focus on emotional expression. This approach can potentially improve psychological well-being through structured group discussions that help participants connect with personal values and life goals. By integrating meaning-centered therapy principles, MCG-BCS aims to address existential concerns often experienced by cancer survivors, offering a unique layer of support not typically found in conventional treatment options.

What evidence suggests that this trial's group interventions could be effective for breast cancer survivors?

Research shows that Meaning-Centered Group Psychotherapy (MCGP), offered in this trial as part of the Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS) arm, can benefit cancer survivors. Studies have found that it enhances personal meaning, mental well-being, and aids in adjusting to life after cancer. Participants often report feeling more focused on their goals and experiencing improved mental health. It can also reduce feelings of depression and enhance overall quality of life. This therapy appears more effective than some others in helping individuals find purpose and set goals. ^{1 5 6 7 8}

Who Is on the Research Team?

Monique James, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who have completed treatment, are over 18 years old, and feel distressed related to their cancer or survivorship. They must be stable on any mood-related medications and have access to a phone and internet. Those with metastatic disease or significant psychiatric issues that prevent informed consent are excluded.

Inclusion Criteria

I feel significant distress related to my breast cancer, scoring 4 or more on the DT.

My medication for mood or sleep issues has been stable and unchanged.

I had breast cancer before, but it did not spread to other parts of my body.

Exclusion Criteria

Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the groups (i.e., acute psychiatric symptoms which require individual treatment)

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Group Intervention

Participants engage in either a Meaning-Centered Group or a Discussion Group to help cope with the emotional burden of breast cancer survivorship

8 weeks

Weekly virtual sessions via telephone and computer

Follow-up

Participants are monitored for the benefits and feasibility of the group interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Manualized Group Intervention
• Standardized, Manualized Group Intervention

Trial Overview The study compares two group interventions for emotional support: a 'Meaning-Centered Group' designed to help find purpose post-treatment, and a 'Discussion Group' for general survivor support. The effectiveness of conducting these groups virtually is also being tested.

How Is the Trial Designed?

Group I: Meaning-Centered Group for Breast Cancer Survivors (MCG-BCS) Experimental Treatment 1 Intervention

Group II: Discussion Group (DG) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

Self-management interventions (SMIs) can help improve health-related quality of life (HRQoL) in breast cancer survivors, particularly in physical and functional well-being, based on a review of nine randomized controlled trials.

While SMIs show potential effectiveness, the improvements in HRQoL are generally small and inconsistent, indicating a need for more rigorous testing and development of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective are self-management interventions in promoting health-related quality of life in people after primary treatment for breast cancer? A critical evidence synthesis. Cheng, L., Kotronoulas, G.[2020]

In a study involving 271 distressed breast cancer survivors, mindfulness-based cancer recovery (MBCR) was found to be more effective than supportive-expressive therapy (SET) in reducing stress symptoms and improving quality of life and social support.

Both MBCR and SET helped maintain healthier cortisol levels over time compared to a control group, indicating that these interventions can positively influence stress-related biological responses in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of Mindfulness-based cancer recovery versus supportive expressive group therapy for distressed survivors of breast cancer. Carlson, LE., Doll, R., Stephen, J., et al.[2022]

The Telephone Counseling Trial for Breast Cancer Survivors aims to improve the quality of life for 400 early-stage breast cancer patients through a structured telephone-based counseling intervention over 12 months, focusing on coping strategies and psychological support.

The study will assess various outcomes, including mood and self-efficacy, at multiple follow-up points (3, 6, 12, and 18 months), potentially establishing a model for future psychosocial interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone counseling of breast cancer patients after treatment: a description of a randomized clinical trial. Marcus, AC., Garrett, KM., Cella, D., et al.[2007]

In a study of 252 distressed breast cancer survivors, mindfulness-based cancer recovery (MBCR) was found to significantly reduce mood disturbances and stress symptoms immediately after the intervention compared to supportive expressive group therapy (SET).

MBCR not only improved psychological well-being more effectively than SET but also provided lasting benefits over a year, helping participants develop long-term coping strategies for dealing with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized-controlled trial of mindfulness-based cancer recovery versus supportive expressive group therapy among distressed breast cancer survivors (MINDSET): long-term follow-up results. Carlson, LE., Tamagawa, R., Stephen, J., et al.[2018]

Patients with cancer are living longer, highlighting the need for diverse psychosocial interventions to support their mental and emotional well-being.

The review identifies four common types of interventions—education, behavioral training, individual psychotherapy, and group interventions—each offering potential psychological and physical health benefits for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical review of psychosocial interventions in cancer care. Fawzy, FI., Fawzy, NW., Arndt, LA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5501751/

Efficacy of Meaning-Centered Group Psychotherapy for ... With respect to the secondary outcomes, support was found that MCGP-CS also improves goal-orientedness, psychological well-being and adjustment to cancer.

2. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/1471-244X-14-22

protocol of a randomized controlled trial | BMC Psychiatry In the proposed study, we aim to evaluate the effectiveness of a newly developed meaning-centered group psychotherapy for cancer survivors, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7199891/

Long‐term efficacy of meaning‐centered group ... Meaning‐centered group psychotherapy for cancer survivors (MCGP‐CS) is an effective intervention to improve personal meaning, psychological well‐being, and ...

4. sigmapubs.onlinelibrary.wiley.com sigmapubs.onlinelibrary.wiley.com/doi/10.1111/wvn.12752

Effectiveness of meaning‐centered interventions on existential ... Existing studies have shown that MCIs have a positive effect on improving QOL, depressive symptoms, and pain in cancer survivors (Cai et al., ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0005789424000418

Meaning-Centered Psychotherapy Versus Cognitive ... This study suggests that MCP could be more effective than CBT in improving meaning in life, purpose, and life goals, and equally effective as CBT in improving ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10590054/

Exploring the experience of meaning-centered group ... The purpose of this study was to employ a qualitative design to explore the experiences and viewpoints of Chinese cancer patients who have undergone MCGP.

7. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=297250

Effects of Psychosocial Treatment on Cancer Survivorship The study showed a decrease in trauma symptoms, improvements in mood disturbance, increase in survival time, and lower increase in pain and suffering. Program ...

8. cancer.jmir.org cancer.jmir.org/2022/1/e31756

Evaluation of the Pathways for Survivors Program to Address ... This study aimed to assess the impact of the Pathways for Survivors program, a 1-day layperson-led workshop for breast cancer survivors, on ...