Telephone Counseling for Depression in Ovarian Cancer Patients

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Bipolar disorder, Psychosis

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

409 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this behavioral research study is to find a quick and effective way to identify depression in patients with ovarian, peritoneal, or fallopian tube cancer. Another goal of this study is to compare an intervention program with "enhanced" standard care to see which may be more effective in improving quality of life for these patients.

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 data supports the effectiveness of the treatment Telephone Counseling for Depression in Ovarian Cancer Patients?

The research on collaborative depression care, like COPE-D, shows that tailored interventions for cancer patients with depression can be feasible and acceptable, suggesting that telephone counseling might also be effective in addressing depression in ovarian cancer patients. ^{1 2 3 4 5}

Is telephone counseling for depression safe for ovarian cancer patients?

There is no specific safety data available for telephone counseling in ovarian cancer patients, but generally, counseling services are considered safe for humans. ^{1 2 3 4 5}

How does usual care for depression in ovarian cancer patients differ from other treatments?

Usual care for depression in ovarian cancer patients typically involves standard medical practices and support, which may not include specialized interventions like telephone counseling. This approach relies on general healthcare services rather than targeted psychological support, making it less personalized compared to treatments specifically designed to address depression in cancer patients. ^{1 2 4 5 6}

Research Team

Eileen H. Shinn, PhD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women over 18 with ovarian, peritoneal, or fallopian tube cancer who are currently receiving treatment. They must speak English at a 7th grade level, be mentally oriented, have a certain level of physical functioning (Zubrod status of 0-2), and consent to participate. They should also be diagnosed with some form of depression but not bipolar disorder or psychosis.

Inclusion Criteria

I am currently being treated for ovarian, peritoneal, or fallopian tube cancer.

I am 18 years old or older.

I have been diagnosed with a form of depression.

Exclusion Criteria

I have been diagnosed with bipolar disorder or psychosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Initial Assessment

Participants complete a questionnaire and SCID interview to assess depression and eligibility for intervention

1 week

1 visit (in-person or virtual)

Intervention

Participants in the intervention group receive 10 weekly telephone calls with cognitive-behavioral techniques

10 weeks

10 visits (virtual)

Standard Care

Participants in the standard care group receive professional resources and referral recommendations

4 months

Follow-up

Participants complete a follow-up questionnaire and SCID interview to assess changes in depression and quality of life

4 months

1 visit (in-person or virtual)

Treatment Details

Interventions

• Telephone Counseling
• Usual Care

Trial Overview The study aims to identify an effective method for detecting depression in patients with specific types of cancer. It compares the effectiveness of telephone counseling versus 'enhanced' usual care in improving life quality for these patients.

Participant Groups

Group I: Usual Care Group Experimental Treatment 1 Intervention

Lists of professional resources and referral recommendations will be provided.

Group II: Intervention Group Active Control 1 Intervention

Weekly phone calls lasting about 30 minutes. Lists of professional resources and referral recommendations will be provided.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Lance Armstrong Foundation

Collaborator

Trials

10

Recruited

1,100+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The COPE-D intervention significantly improved depression and quality of life for underserved cancer patients, with 65% of participants showing treatment improvement and 56% achieving a significant treatment response.

Outcomes such as suicidal ideation, anxiety, sleep disturbance, and social isolation also improved, indicating the intervention's broad effectiveness across various mental health aspects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative depression care sensitive to the needs of underserved patients with cancer: Feasibility, acceptability and outcomes. Price, S., Hamann, HA., Halaby, L., et al.[2023]

References

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

Comparison of four brief depression screening instruments in ovarian cancer patients: Diagnostic accuracy using traditional versus alternative cutpoints. [2021]

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

Agreement for depression diagnosis between DSM-IV-TR criteria, three validated scales, oncologist assessment, and psychiatric clinical interview in elderly patients with advanced ovarian cancer. [2018]

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

Collaborative depression care sensitive to the needs of underserved patients with cancer: Feasibility, acceptability and outcomes. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Depression and anxiety in ovarian cancer: a systematic review and meta-analysis of prevalence rates. [2023]

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

Depression, correlates of depression, and receipt of depression care among low-income women with breast or gynecologic cancer. [2022]

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

Effectiveness of advanced nursing care on depression in patients with ovarian cancer: A protocol of systematic review of randomized controlled trial. [2022]