The Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention for Families Affected by Parental Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Feasibility of Study Procedures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Because this is a pilot study, all participant dyads will receive the same intervention and no blinding will take place.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for patients:
- •Be a woman with metastatic (stage IV) breast cancer who has either: (1) estrogen (ER), progesterone (PR), or HER2 receptor-negative cancer and disease progression beyond first line of therapy, or (2) ER, PR, or HER2 -positive cancer and disease progression beyond two lines of therapy;
- •A mother of at least one dependent child, defined as a child <18 years of age who lives at least half-time in the home;
- •Be at least 18 years of age;
- •Adequate stamina to complete at least two study visits
- •Able to provide informed consent
- •Able to complete all study measures and visits in English;
- •Be willing to participate in study visits at the North Carolina Cancer Hospital (NCCH) if they live >75 miles away from NCCH
- •Have an identified co-parent who is eligible and willing to participate in the study.
- •Inclusion Criteria for Co-parents:
- •Be an adult man or woman who is both a partners or spouse of the patient and who would serve as the child(ren)'s primary caregiver if the patient were to become unavailable;
- •Able to provide informed consent;
- •Able to complete all study measures and visits in English;
- •Stated willingness to comply with all study procedures; and
- •Be at least 18 years of age.
排除标准
- •for patients and co-parents:
- •Unable to participate in study visits due to illiteracy, inability to speak English or other causes.
- •Live more than 75-miles away from the North Carolina Cancer Hospital (NCCH) and unable to attend study visits at NCCH (participants who live more than 75-miles away and can attend study visits at NCCH remain eligible for participation).
- •Unwilling to be audio-recorded during facilitated study visits and feedback interview.
研究组 & 干预措施
FAMILY
Patient-co-parent dyads will participate in the FAMILY intervention in-person.
干预措施: FAMILY Intervention (Behavioral)
结局指标
主要结局
Feasibility of Study Procedures
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS)(Baseline, 7 Days, 14 Days, 28 Days, 42 Days)
- The Change in Patient and Co-parent's Illness-related Communication(Baseline, 7 Days, 14 Days, 28 Days, 42 Days)
- Patient's Health-related Quality of Life(Baseline, 7 Days, 14 Days, 28 Days, 42 Days)
- Patient and Co-parent's Cancer-related Family Communication(Baseline, 7 Days, 14 Days, 28 Days, 42 Days)
- Feasibility of Completion(Up to 42 Days)
- Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD)(Baseline, 7 Days, 14 Days, 28 Days, 42 Days)