NCT03532061

Brief Summary

Caregiver education and training programs that specifically target caregiver informational and training needs during the survivorship period have been limited. In recognition of families' direct involvement in health care decision-making, health advocacy and care provision, programs are needed that can maximize families' caregiving abilities and skills and provide them with the information and resources they may need to identify and address elderly cancer patients' post-treatment symptom management. The goal of this study was to implement and evaluate the efficacy of a short-term problem-solving skills training program (relative to participating in a caregiver support group) for familial caregivers to lower income older (55+) post-treatment cancer patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2011

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
Last Updated

November 3, 2022

Status Verified

May 1, 2019

Enrollment Period

4.7 years

First QC Date

April 5, 2018

Last Update Submit

October 31, 2022

Conditions

Keywords

Familial CaregiverCancerSymptom ManagementCOPE PrinciplesProblem-solving Skills Training Program

Outcome Measures

Primary Outcomes (1)

  • Change in Caregiver Social Problem-Solving Inventory Scale Score

    Social Problem-Solving Inventory-Revised (SPSI-R:L): This is a 52 item instrument that measures one's ability to resolve problems encountered in everyday living. Scoring results in five standardized scale scores (1. Positive problem orientation; 2. Negative problem orientation; 3. Impulsivity/carelessness style; 4. Avoidance style; and 5. Rational problem solving), four Rational Problem Solving subscale scores (1. Problem definition formulation; 2. Generation of alternative solutions; 3. Decision making; and 4. Solution implementation and verification) and a Total SPSI-R:L standard score. Raw scores are converted to standard scores. The total SPSI-R:L score and each scale/subscale score has a mean of 100 and a standard deviation of 15. With the total SPSI-R:L score, higher scores indicate "good" social problem-solving ability. The extent to which "good" and "poor" problem-solving ability is demonstrated, is determined by observing how far the scores are from the mean score of 100.

    Baseline, 1 & 7 months post-intervention delivery

Secondary Outcomes (1)

  • Caregiver's Satisfaction with Quality of Patient Care - FAMCARE Scale Score

    Baseline, 1 & 7 months post-intervention delivery

Study Arms (2)

FamCare Group

EXPERIMENTAL

Family caregivers who receive 6 in-person problem-solving skills training sessions (FamCare Program).

Behavioral: FamCare Program

Caregiver Support Group

ACTIVE COMPARATOR

Family caregivers who receive 6 in-person caregiver support group sessions.

Other: Caregiver Support Group

Interventions

FamCare ProgramBEHAVIORAL

6 in-person sessions of biweekly home care problem-solving skills training (FamCare) delivered by a health educator.

FamCare Group

6 in-person caregiver support group sessions held biweekly and moderated by a health educator.

Caregiver Support Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a cancer diagnosis
  • Have completed active treatment
  • Be an older adult, aged 55 or older
  • Have a family member who is their caregiver
  • Understand English or Spanish
  • Not be severely cognitively impaired

You may not qualify if:

  • Patient must be in the post-treatment period
  • Be 18 or older
  • Live with or have frequent (at least weekly face-to-face) contact with patient
  • Understand English or Spanish
  • Not be severely cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Raveis VH, Tobin J, Karus D, Zhou R, Faber KE, Carrero M, Estrada I. Family caregiving to older, minority cancer survivors living in the community: Perspectives from a randomized control trial of caregiver problem-solving skills training. The Gerontologist 51(S2):496, 2011.

    BACKGROUND
  • Raveis VH, Tobin J, Karus D, Faber K, Zhou R, Carrero M, Estrada I. Family caregiving transitions: Addressing the care needs of older adults during the cancer survivorship period. The Gerontologist 50(S1): 475, 2010.

    BACKGROUND
  • Raveis VH, Karus D, Zhou R, Carrero-Tagle M, Faber K, Estrada I, Tobin JN. FamCare: Cognitive-behavioral problem solving training for family caregivers to cancer survivors. Gerontologist 56(Suppl_3): 684, 2016.

    RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Victoria H. Raveis, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2018

First Posted

May 22, 2018

Study Start

August 7, 2006

Primary Completion

April 14, 2011

Study Completion

July 31, 2011

Last Updated

November 3, 2022

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share