Psychotherapy for Cancer

Overseen By Christian Nelson, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antidepressants

Disqualifiers: Hospice care, Major psychotic disorder, others

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

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

409 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to see if a new psychotherapy intervention called Cancer and Aging: Reflections for Elders (CARE) can effectively treat depression and distress in older cancer patients. CARE is a 5-session intervention that takes place over the phone. This study will compare CARE with the Social Work and Supportive Counseling (SWSC) intervention, which also takes place over the phone. SWSC is a standard psychotherapeutic intervention that has been shown to be a supportive and effective form of treatment for distress for patients with cancer. The researchers will look at which intervention is more effective in treating depression and distress in participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been taking antidepressant medication for less than 3 months.

What data supports the effectiveness of the CARE Intervention treatment for older adults with cancer?

The CARE Intervention treatment, which is delivered over the phone, has shown initial success in reducing distress in older cancer patients by using age-appropriate themes and coping strategies. Additionally, similar interventions tailored to older adults have been effective in improving quality of life and care for cancer patients. ^{1 2 3 4 5}

Is psychotherapy for cancer, such as the CARE Intervention, safe for humans?

The available research does not provide specific safety data for the CARE Intervention or similar psychotherapy treatments for cancer patients, but these interventions are generally designed to support mental well-being and are considered safe for human use. ^{1 4 6 7 8}

How is the CARE Intervention treatment different from other treatments for older adults with cancer?

The CARE Intervention is unique because it is a telephone-delivered therapy specifically designed for older adults with cancer, focusing on age-appropriate themes and coping strategies to reduce distress. It integrates developmental life stage theories and cognitive coping methods to help patients achieve a sense of acceptance and meaning in their illness. ^{1 4 9 10 11}

Research Team

Christian Nelson, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for older adults (70+) with cancer, who are currently undergoing treatment or have been treated within the past 6 months. They should be able to care for themselves mostly (KPRS score ≥ 60), think clearly (BOMC ≤ 11), and speak English well. It's not for those in hospice care, unable to consent, on new antidepressants (<3 months), or with untreated major psychotic disorders.

Inclusion Criteria

I am currently undergoing cancer treatment or have completed it within the last 6 months.

I am currently undergoing treatment for my condition, or I have been treated in the past 6 months, or I am on active surveillance.

Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for training case participants)

Exclusion Criteria

My preferred language for healthcare is English.

As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.

Language verification: Prior to enrollment, patients will be asked the following two questions by research staff to verify English fluency necessary for participation in the study:

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the CARE or SWSC intervention over the phone, consisting of five sessions over an 8-week period

8 weeks

5 sessions (phone)

Booster Sessions

Participants receive four brief booster sessions to extend the intervention to 6 months

3 months

4 sessions (phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Treatment Details

Interventions

• Cancer and Aging: Reflections for Elders (CARE) Intervention
• Social Work and Supportive Counseling (SWSC) Intervention

Trial Overview The study tests a new psychotherapy called CARE against an existing therapy known as SWSC. Both aim to reduce depression and distress in older cancer patients through five phone sessions. The effectiveness of each method will be compared.

Participant Groups

Group I: Social Work and Supportive Counseling (SWSC) Experimental Treatment 1 Intervention

The SWSC will include a social work assessment and follow-up augmented with additional components of supportive psychotherapy that have been shown to be an effective form of treatment for patients with cancer. Five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).

Group II: Cancer and Aging: Reflections for Elders (CARE) Intervention Experimental Treatment 1 Intervention

Session content and timing was developed and confirmed in our qualitative work (Expert Panel) and the CARE pilot study. Five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

The CARE intervention, a telephone-delivered psychotherapy for older cancer patients, was found to be feasible and tolerable, with 59 participants completing the study and meeting criteria for eligibility and retention.

Participants in the CARE group showed a significant reduction in depression scores after the intervention, indicating its potential efficacy in improving mental health among older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer and Aging: Reflections for Elders (CARE): A pilot randomized controlled trial of a psychotherapy intervention for older adults with cancer. Nelson, CJ., Saracino, RM., Roth, AJ., et al.[2020]

The Oncology Social Work Intervention Index (OSWii) was developed to measure the range of psychosocial interventions provided by oncology social workers (OSWs) and was tested with 38 OSWs across 156 cases, showing that OSWs primarily engage in clinical interventions (72% of their time).

The OSWii was found to be user-friendly and relevant for the cancer treatment setting, indicating its potential to standardize the measurement of psychosocial care and improve research on the impact of these interventions on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology social work intervention index (OSWii): An instrument to measure oncology social work interventions to advance research. Oktay, JS., Rohan, EA., Burruss, K., et al.[2023]

Approximately one third of cancer patients are identified as high-risk for psychosocial problems, yet only 15-25% actually utilize psychosocial oncology services, indicating a gap in service use among those in need.

Current intervention research in psychosocial oncology lacks adequate representation of diverse populations, including minorities and non-traditional clients, highlighting the need for improved access and participation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organizing social work services with adult cancer patients: integrating empirical research. Cwikel, JG., Behar, LC.[2005]

The coping and communication support (CCS) intervention is specifically designed to meet the unique needs of older cancer patients, addressing their engagement and communication challenges during treatment.

In a study comparing older and middle-aged patients, both groups showed similar levels of engagement and issues faced, suggesting that the CCS intervention is effective across age groups and may improve quality of care and life for late-stage cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A coping and communication support intervention tailored to older patients diagnosed with late-stage cancer. Rose, JH., Radziewicz, R., Bowmans, KF., et al.[2023]

Longer nursing interventions, such as a 12-month program, are more effective in providing continuity of care for older adults with cancer compared to shorter programs, highlighting the need for sustained support as patients transition between different types of care.

Nurses play a crucial role in improving cancer screening rates and symptom management, especially in rural areas where resources may be limited, emphasizing the importance of the nurse-patient relationship in achieving better health outcomes for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing intervention and older adults who have cancer: specific science and evidence based practice. Bourbonniere, M., Kagan, SH.[2005]

A study of 19,865 prostate cancer patients across 102 centers in Germany and Switzerland found that 51% of the variation in social service counseling (SSC) utilization is due to the specific cancer center, highlighting significant differences in how centers provide these services.

Certain patient characteristics, such as being older than 80, having higher education, and undergoing specific treatments like primary radiotherapy, were associated with lower SSC utilization, suggesting that both patient and center-level factors influence access to these important support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors for the utilization of social service counseling by prostate cancer patients. Breidenbach, C., Ansmann, L., Sibert, NT., et al.[2022]

In a study of 6339 breast cancer patients across 13 certified centers in Germany, 80.3% utilized social service counseling (SSC), indicating a high level of access to support services.

Utilization of SSC varied significantly based on patient characteristics, with women, those with invasive diseases, and older patients being more likely to use these services, highlighting the influence of sociodemographic factors on access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of social service counseling by cancer patients: an analysis of quality assurance data of 6339 breast cancer patients from 13 certified centers in Germany treated between 2015 and 2017. Breidenbach, C., Wesselmann, S., Sibert, NT., et al.[2021]

A national survey of oncology social workers revealed that most are actively screening cancer patients for psychosocial distress using standardized tools, highlighting their crucial role in providing psychosocial care.

Social workers who believe in the benefits of screening and are knowledgeable about guidelines are more likely to effectively implement these screening procedures, indicating that education and awareness can enhance patient support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for psychosocial distress: a national survey of oncology social workers. BrintzenhofeSzoc, K., Davis, C., Kayser, K., et al.[2018]

The proposed intervention model for elderly cancer patients combines Erik Erikson's psychosocial development theory with cognitive coping strategies, emphasizing the importance of achieving ego integrity to combat feelings of despair.

This model aims to enhance psychological resilience by using cognitive reappraisal techniques in group settings, helping older patients cope with depression and isolation related to their illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reappraisal in the eighth life cycle stage: a theoretical psychoeducational intervention in elderly patients with cancer. Holland, J., Poppito, S., Nelson, C., et al.[2018]

Out of 41 studies on psychosocial care for cancer patients, 35 demonstrated significant positive effects on coping, mood states, or quality of life, highlighting the efficacy of psychological interventions in cancer treatment.

Six studies investigated the impact of psychosocial care on survival time, while three focused on its effects on the immune system, suggesting a potential link between psychological support and physical health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of psychosocial management of cancer patients--a critical review of empirical studies (status: December 1990)]. Frischenschlager, O., Brömmel, B., Russinger, U.[2006]

A pilot study found that two-thirds of older cancer patients reported experiencing significant psychological concerns, highlighting the need for better support systems.

Nearly 50% of these patients felt they did not receive adequate help for their emotional needs, and 69% lacked sufficient spiritual support, indicating a gap in care that could be addressed by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial needs of older cancer patients: a pilot study abstract. Houldin, AD., Wasserbauer, N.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Cancer and Aging: Reflections for Elders (CARE): A pilot randomized controlled trial of a psychotherapy intervention for older adults with cancer. [2020]

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

Oncology social work intervention index (OSWii): An instrument to measure oncology social work interventions to advance research. [2023]

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

Organizing social work services with adult cancer patients: integrating empirical research. [2005]

4. New Zealand pubmed.ncbi.nlm.nih.gov

A coping and communication support intervention tailored to older patients diagnosed with late-stage cancer. [2023]

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

Nursing intervention and older adults who have cancer: specific science and evidence based practice. [2005]

6. Germany pubmed.ncbi.nlm.nih.gov

Predictors for the utilization of social service counseling by prostate cancer patients. [2022]

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

Use of social service counseling by cancer patients: an analysis of quality assurance data of 6339 breast cancer patients from 13 certified centers in Germany treated between 2015 and 2017. [2021]

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

Screening for psychosocial distress: a national survey of oncology social workers. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Reappraisal in the eighth life cycle stage: a theoretical psychoeducational intervention in elderly patients with cancer. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

[Effectiveness of psychosocial management of cancer patients--a critical review of empirical studies (status: December 1990)]. [2006]

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

Psychosocial needs of older cancer patients: a pilot study abstract. [2015]