Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention

Not Applicable

Terminated

Conditions: Parenting
Metastatic Breast Cancer

Interventions: Behavioral: FAMILY Intervention

Registration Number: NCT04092816

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary: This is a single-arm pilot study to evaluate the feasibility and acceptability of a novel psychosocial intervention to improve psychosocial outcomes for parents with advanced cancer and their co-parents. In this single-center study, we will recruit ten mothers with metastatic breast cancer and their co-parents as dyads (N=20) to participate in the Fathers and Mothers Invested in the Lives of their Youth (FAMILY) intervention. Patient and co-parent dyads will participate in 2-3 study visits with an intervention facilitator and a post-intervention feedback interview. Participants will also complete baseline and follow-up study surveys. The final products of this study will be the FAMILY intervention manual and training materials, and fidelity assessments.

Detailed Description: Cancer is the leading disease-specific cause of early parental death in the United States and having dependent children worsens suffering for parents with advanced cancer and their families. The FAMILY intervention consists of manualized visits with a trained intervention facilitator and psychoeducation materials to help parents cope with cancer-related parenting concerns. The purpose of the intervention is to improve parenting concerns, emotional well-being, and end-of-life (EOL) preparation among participants. This study will evaluate whether a psychosocial intervention to reduce psychological distress and improve EOL preparation for mothers with metastatic breast cancer and their co-parents can be acceptable, feasible, and relevant to the target patient population.

This study is needed in order to generate critical data to: (1) refine the intervention in preparation for a pilot efficacy randomized controlled trial (RCT); and to generate preliminary data demonstrating the feasibility and acceptability of core intervention components. The preliminary data will support future grant applications for a full-scale efficacy RCT.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FAMILY	FAMILY Intervention	Patient-co-parent dyads will participate in the FAMILY intervention in-person.

Primary Outcome Measures

Name	Time	Method
Feasibility of Study Procedures	14 Days	Feasibility of study procedures were assessed how likely patient-co-parent dyads are to join the study through tracking the number of eligible dyads who participate in the study.
Feasibility of Recruitment	Baseline	Assess how likely patient-co-parent dyads are to join the study by tracking the number of eligible dyads who participate in the study.
Acceptability of the Intervention	42 Days	Acceptability of the intervention was defined as the number of participants who completed the study intervention. Participants' experience was assessed qualitatively, using post-intervention interviews.
Acceptability of the Intervention Measured by the Study Visit Assessment Form	7 Days	The acceptability of the intervention was assessed through participants' satisfaction with the program. The Lyon Satisfaction questionnaire consists of 5-point Likert-type items assessing positive (six items) and negative (seven items) emotional reactions to the study visit. Responses were summed and reported for each subscale with higher scores meaning higher emotional reactions, and worse reactions. Positive subscale: 6-30 and negative subscale: 7-35.

Secondary Outcome Measures

Name	Time	Method
Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale	Baseline, 7 Days, 14 Days, 28 Days, 42 Days	Assess the change in patient's emotional well-being through the FACIT-Pal Care; a 6-item self-report assessment of emotional well-being that is widely used in palliative care research. Score range is 0-24, higher scores indicate better emotional well-being.
Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS)	Baseline, 7 Days, 14 Days, 28 Days, 42 Days	Assess the change in patient and co-parent's depression and anxiety symptom severity. The HADS consists of two 7-item subscales assessing depression and anxiety symptoms separately. Score range for each subscale is 0-21, higher scores indicate greater symptoms.
The Change in Patient and Co-parent's Illness-related Communication	Baseline, 7 Days, 14 Days, 28 Days, 42 Days	The change in patient and co-parent's illness-related communication was measured by the Couples Illness Communication Scale (CICS). The CICS is a brief self-report measure of illness-related couple communication. The CICS consists of 4 items measured on a 5-point Likert-type scale. Total Score Range: 4-20, Higher is better.
Patient's Health-related Quality of Life	Baseline, 7 Days, 14 Days, 28 Days, 42 Days	Patient Health-related Quality of Life was assessed change in the patient's health-related quality of life measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal). The FACIT-Pal is a 46-item self-administered assessment of general HRQOL in cancer patients. It is graded on a 4-point scale and higher scores indicate better quality of life. Total Score Range: 0-184 Assess change in the patient's health-related quality of life measured by the FACIT-Pal; the FACIT-Pal is a 46-item self-administered assessment of general HRQOL in cancer patients. It is graded on a 4-point scale and higher scores indicate better quality of life. The numbers analyzed reflect all individuals who contributed data at each time point.
Patient and Co-parent's Cancer-related Family Communication	Baseline, 7 Days, 14 Days, 28 Days, 42 Days	Patient and Co-Parent's Cancer-related Family Communication was assessed changes in the patient and co-parent's scores for a nine-item investigator-developed measure. The measure assesses participants' confidence and preparation to engage in communication about the impact of parental cancer on children. For the first 8 items, the score range is on a 4-point scale (1 to 4). The last item is graded on a 3-point scale (1 to 3). For all 9 items, higher is better. Due to the small sample size, each individual score item was reported.
Feasibility of Completion	Up to 42 Days	Feasibility of Completion was evaluated by tracking the number of dyads that complete the study visits and study assessments. Numbers reflect from Baseline through 42 days given a flexible duration of intervention.
Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD)	Baseline, 7 Days, 14 Days, 28 Days, 42 Days	Assess the change in patient and co-parent's parenting concerns severity. The PCQ-AD is an investigator-adapted measure of parenting concerns measured on a 4-point scale. Total score range for the PCQ-AD is 0-3 with higher scores indicating greater distress.