Group Interventions for Breast Cancer Survivors

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

104 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Manualized Group Intervention, Standardized, Manualized Group Intervention for breast cancer survivors?

Research shows that structured group interventions, like supportive-expressive group therapy, can improve psychological wellbeing, reduce anxiety and depression, and enhance quality of life for cancer patients. These therapies help patients cope better by providing emotional support and stress management strategies. ^{1 2 3 4 5}

Is the Manualized Group Intervention safe for breast cancer survivors?

Group interventions, like the ones studied for cancer and HIV, are generally considered safe and are used widely in supportive care settings. They focus on providing emotional and social support, which can be beneficial for overall well-being. ^{1 6 7 8 9}

How is the Manualized Group Intervention treatment unique for breast cancer survivors?

The Manualized Group Intervention is unique because it provides structured group support, which can help breast cancer survivors improve their quality of life by offering emotional and social support, unlike individual therapies that may not address these aspects. ^{1 6 8 10 11}

What is the purpose of this trial?

The purpose of this study is to compare two types of groups for breast cancer survivors: a Meaning-Centered Group and a Discussion Group. Many breast cancer survivors seek help to deal with the emotional burden of having gone through the cancer experience. Participation in groups offering support often helps cancer survivors cope with stressors of life after having had cancer by giving them a place to express their feelings. The "Meaning-Centered Group" is intended to teach breast cancer survivors how to maintain or even increase a sense of meaning and purpose in their lives after treatment for cancer. The "Discussion Group" is intended to help breast cancer survivors cope by giving them a place to get support from other breast cancer survivors. The goal of this study is to compare the benefits of these two types of group approaches for breast cancer survivors. The study is also testing the benefits and feasibility of conducting the groups virtually using a telephone and computer.

Research Team

Monique James, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Randomized controlled trial of Mindfulness-based cancer recovery versus supportive expressive group therapy for distressed survivors of breast cancer. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Support groups for cancer patients. [2022]

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

Critical review of psychosocial interventions in cancer care. [2022]

4. England 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. [2018]

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

Supportive-expressive group therapy for primary breast cancer patients: a randomized prospective multicenter trial. [2022]

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

Group interventions for patients with cancer and HIV disease: part IV. Clinical and policy recommendations. [2010]

7. England pubmed.ncbi.nlm.nih.gov

Telephone counseling of breast cancer patients after treatment: a description of a randomized clinical trial. [2007]

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

Group support interventions for women with breast cancer: who benefits from what? [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Survivorship wellness: a multidisciplinary group program for cancer survivors. [2023]

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

Group interventions for patients with cancer and HIV disease: Part III. Moderating variables and mechanisms of action. [2010]

11. Scotland 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. [2020]