Telephone Counseling for Depression in Ovarian Cancer Patients

Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores methods to identify and treat depression in women undergoing treatment for ovarian, peritoneal, or fallopian tube cancer. It compares usual care, which includes resource lists and referrals, with an intervention of weekly 30-minute phone calls for additional support (telephone counseling). The goal is to determine which method better enhances the quality of life for these patients. Women currently receiving treatment for these cancers and experiencing depression may be suitable candidates for the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative support.

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 prior data suggests that telephone counseling is safe for depression in ovarian cancer patients?

Past studies have shown that telephone counseling for cancer patients is safe and sometimes helpful. Research indicates that both online and in-person counseling can reduce emotional distress and alleviate post-traumatic stress symptoms without major safety concerns. Additionally, a study on mobile phone app-based programs found them well-received and beneficial for mental health in cancer survivors.

This trial is in an early stage, focusing primarily on safety. While specific data may be limited, early-stage studies generally aim to ensure treatments are safe for participants. Existing evidence from other studies suggests that telephone counseling is a safe option for those considering joining the trial.12345

Why are researchers excited about this trial?

Researchers are excited about the telephone counseling approach for depression in ovarian cancer patients because it offers a unique method of support. Unlike typical treatments that might involve medication or in-person therapy sessions, this approach provides weekly phone calls that are accessible and convenient for patients. This method could make it easier for patients to receive consistent emotional support and resources, potentially improving mental health outcomes without the need for travel or scheduling conflicts. This trial could reveal whether this flexible support system is effective in managing depression for those undergoing the challenges of ovarian cancer.

What evidence suggests that telephone counseling is effective for depression in ovarian cancer patients?

Research has shown that talking to a counselor over the phone can reduce stress and anxiety, especially after receiving difficult medical news, such as a positive BRCA1/2 test result. For women with gynecological cancers, this counseling might also alleviate feelings of depression. In this trial, participants in the Intervention Group will receive weekly 30-minute phone calls, which may improve depression and sleep problems over time. Some studies have found that phone support leads to noticeable improvements in these areas. Specifically, one study found that people who received phone support for depression reported feeling better after six months. These findings suggest that phone counseling could effectively improve mental health for cancer patients.34678

Who Is on the Research Team?

EH

Eileen H. Shinn, PhD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 have been diagnosed with a form of depression.
I am aware of the current time, who I am, and where I am.
See 3 more

Exclusion Criteria

I have been diagnosed with bipolar disorder or psychosis.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care GroupExperimental Treatment1 Intervention
Group II: Intervention GroupActive Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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]

Citations

Randomized Controlled Trial of a Psychosocial Telephone ...Psychosocial telephone counseling delivered following disclosure of positive BRCA1/2 test results appears to offer modest benefits for distress and anxiety.
The effectiveness of cognitive behavioral therapy in women ...The coping and communication-enhancing intervention may be effective in treating depressive symptoms among patients with gynecological cancer.
Depression Treatment and Screening in Ovarian Cancer ...The goal of this behavioral research study is to find a quick and effective way to identify depression in patients with ovarian, peritoneal, ...
A Novel Mobile Phone App Intervention With Phone Coaching ...Results: There were significant decreases in symptoms of depression and sleep disruption from baseline to postintervention. Sleep disruption ...
Effectiveness of a Telephone-Supported Depression Self ...Among 245 participants randomly assigned, 218 (89.0%) completed the primary outcome at 6 months. CanDirect participants reported less severe ...
Internet-Based Group Intervention for Ovarian Cancer ...Preliminary data suggest decreases in perceived stress and improvements in QOL, following the intervention. An Internet-based group may be ...
Virtual Care in Patients with Cancer: A Systematic Review - PMCEmotional distress and post-traumatic stress symptoms improved in on-line counselling and in-person counselling groups; there were no ...
Mental health disorders among ovarian cancer survivors in ...The risks of depression among ovarian cancer survivors were nearly 3-fold within the first 2 years of cancer diagnosis (HR = 2.59, 95% CI = 1.94 ...
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