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

459 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new phone-based therapy, Cancer and Aging: Reflections for Elders (CARE) Intervention, can reduce depression and distress in older cancer patients. The study will compare CARE with another phone-based therapy, Social Work and Supportive Counseling (SWSC), to assess which is more effective. Each therapy involves five sessions over eight weeks, followed by monthly booster sessions for six months. This trial suits individuals aged 70 or older who are currently dealing with cancer and experiencing depression or distress. As an unphased trial, it offers a unique opportunity for patients to contribute to innovative research that could enhance mental health care for older adults with cancer.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the CARE program is well-received by older adults with cancer. Early findings suggest it is easy to use and positively affects emotional well-being. Participants in earlier studies reported feeling less depressed after completing the program, indicating it may boost mood without negative effects.

For the SWSC program, studies have found that supportive counseling effectively helps cancer patients who feel distressed. Social workers commonly use this type of counseling in cancer care, and it is generally safe for patients.

Overall, both the CARE and SWSC programs appear to be safe options for helping older cancer patients manage depression and distress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for cancer patients because they focus on the psychological and emotional well-being of older individuals, which is often overlooked in standard cancer treatments like chemotherapy or radiation. The CARE Intervention provides a unique blend of therapeutic reflection sessions tailored for elders, fostering emotional resilience and coping strategies over a series of structured meetings. On the other hand, the SWSC Intervention combines traditional social work assessments with supportive psychotherapy, enhancing the emotional support system for patients. Both approaches extend their impact with booster sessions, aiming to provide lasting benefits over six months, a feature that distinguishes them from many current psychological support options that may not offer such prolonged engagement.

What evidence suggests that this trial's treatments could be effective for depression and distress in older cancer patients?

Research has shown that the Cancer and Aging: Reflections for Elders (CARE) program, a treatment option in this trial, can reduce depression in older cancer patients. Previous studies found that participants had lower depression scores and showed significant improvements.

Similarly, Social Work and Supportive Counseling (SWSC), another treatment option in this trial, effectively helps cancer patients manage distress. Research has demonstrated that it reduces depression and anxiety while improving quality of life and coping skills.

Both programs in this trial provide valuable support for managing depression and distress in older cancer patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Christian Nelson, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30296337/

Cancer and Aging: Reflections for Elders (CARE): A pilot ... Upon completion of the intervention, participants in the CARE arm demonstrated lower mean depression scores (d = 0.58 [CI: 0.04-1.12], P = 0.01) and trended ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6476184/

Cancer and Aging: Reflections for Elders (CARE): A pilot ... These pilot data suggest the CARE intervention is feasibly delivered by a range of clinicians and provides a positive signal that the CARE ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406822000376

Cancer and aging: Reflections for elders- Expressive ... At post-intervention, participants receiving CARE-Express reported less depression compared to ESWC (d = 0.69, p = 0.01) and lower demoralization (d = 0.50, p = ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pon.4907

Cancer and Aging: Reflections for Elders (CARE): A pilot ... These pilot data suggest the CARE intervention is feasibly delivered, potentially impacts important psychosocial variables, and is accessible ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04452825

A New Psychotherapy Intervention for Older Cancer Patients This study is being done to see if a new psychotherapy intervention called Cancer and Aging: Reflections for Elders (CARE) can effectively treat depression ...

6. researchgate.net researchgate.net/publication/328155266_Cancer_and_Aging_Reflections_for_Elders_CARE_A_Pilot_Randomized_Controlled_Trial_of_a_Psychotherapy_Intervention_for_Older_Adults_with_Cancer

Cancer and Aging: Reflections for Elders (CARE): A Pilot ... Upon completion of the intervention, participants in the CARE arm demonstrated lower mean depression scores (d=0.58 (CI: 0.04‐1.12), p=0.01) and trended towards ...

7. mskcc.org mskcc.org/cancer-care/clinical-trials/20-191

CARE: A Study Comparing the Effectiveness of Two ... This purpose of this study is to assess two interventions to improve cancer care for older adults with cancer.