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A New Psychotherapy Intervention for Older Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452825
Recruitment Status : Active, not recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date June 26, 2020
First Posted Date June 30, 2020
Last Update Posted Date June 30, 2020
Actual Study Start Date June 9, 2020
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2020)
Depression and Anxiety: Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 9 months ]
This 14-item scale, which has been well tested in cancer populations including elderly patients with cancer, has depression and anxiety subscales of seven items each. It is considered particularly useful for patients with chronic disease because of the absence of somatic items that often confound the determination of psychiatric problems among the medically ill.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A New Psychotherapy Intervention for Older Cancer Patients
Official Title Cancer and Aging Reflections for Elders (CARE): A Geriatric-Specific Psychotherapy for Older Adults With Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Potential MSK participants will be identified by the MSK study investigators, the patient's treating physician, or review of the clinic lists. Since we plan to recruit all patients 70 years of age or older, regardless of type of cancer, we will also identify potential patients by query of MSK institutional databases (e.g., DaVinci, Dataline). Once the list is created, members of the protocol research team will verify the medical eligibility against the patient's medical record prior to contacting the patient regarding participation. Once identified as eligible, the patient will be approached at their next clinic visit by an CRC who will provide detailed information about the study.
Condition Cancer
Intervention
  • Behavioral: Cancer and Aging: Reflections for Elders (CARE) Intervention
    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).
  • Behavioral: Social Work and Supportive Counseling (SWSC) 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).
Study Groups/Cohorts
  • Cancer and Aging: Reflections for Elders (CARE) 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).
    Intervention: Behavioral: Cancer and Aging: Reflections for Elders (CARE) Intervention
  • Social Work and Supportive Counseling (SWSC)
    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).
    Intervention: Behavioral: Social Work and Supportive Counseling (SWSC) Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 26, 2020)
476
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2025
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • As per self-report or medical record, ≥ 70 years of age
  • As per self-report or medical record, has a diagnosis of cancer
  • As per self-report or medical record, receiving active treatment (e.g., radiation, chemotherapy, hormone); OR received active treatment in the past 6 months
  • Received a HADS-D score of ≥ 6
  • Received a Karnofsky Performance Rating Scale (KPRS) score of ≥ 60
  • Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11
  • Fluent in English, as per self-reported fluency of "very well"*

Exclusion Criteria:

  • As per self-report, currently taking antidepressant medication for < 3 months
  • As per self-report, currently receiving hospice care
  • In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment
  • 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:

      1. How well do you speak English? (must respond "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
      2. What is your preferred language for healthcare? (must respond English)
Sex/Gender
Sexes Eligible for Study: All
Ages 70 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04452825
Other Study ID Numbers 20-191
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Christian Nelson, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date June 2020