Enhancing Connections-Palliative Care: A Cancer Parenting Program for Patients With Advanced Cancer and Their Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Treatment Efficacy Assessed by Parents' Mood-Center for Epidemiological Studies-Depression (CES-D)
研究概览
简要总结
This trial examines the usefulness of two educational programs for parents with late-stage cancer who have a 5 - 17 year old child. The programs are designed to enhance the quality of the parent-child relationship and add to the parent's confidence in managing the impact of their cancer on their child. Educational programs may reduce anxiety and depression and improve the well-being and quality of life of parents with advanced cancers and their children.
Recruitment occurs nationally via referral to the Fred Hutch/University of Washington Cancer Consortium team.
详细描述
OUTLINE: Patients are randomized to 1 of 2 groups. Co-inhabiting non-ill parent or parent surrogate is also randomized with the patient but only the patient receives either the experimental or control group information.
GROUP I (ENHANCING CONNECTIONS-PALLIATIVE CARE [EC-PC] PROGRAM): Patients receive the 5-session EC-PC program bi-weekly with a patient educator about ways to help them talk to and support their child.
Group I had 2 arms: Arm 1: Ill parents Arm 2: Non-ill parents. The enrolled non-ill parent did not provide data to evaluate the efficacy of the trial.
GROUP II (CONTROL): Patients receive carefully selected educational booklet that discuss ways to talk about their cancer with their child and a scripted phone call from a trained phone counselor on study.
Group II had 2 arms: Arm 1: Ill parents Arm 2: Non-ill parents. The enrolled non-ill parent did not provide data to evaluate the efficacy of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Only biostatistician will be unmasked.
入排标准
- 年龄范围
- 23 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents with any type of late-stage, non-curable cancer (determined by TNM stage IV cancer for solid tumors or 2 or more cycles of treatment failure with disease relapse in non-solid tumors)
- •All therapies are allowable
- •23 years (yr.) to 68 yr. Age restriction exists for the patient based on parent having a child ages 5-17
- •Patient must have a child (5yr. -17 yr.) living in the home at least 50% of the time and residential with non-ill parent or parent surrogate
- •Read and write English as one of their languages of choice
- •Have access to a telephone
- •Ability to understand and the willingness to sign a written informed consent document. Read and write English as one of their languages of choice
排除标准
- •Patient is in hospice at time of enrollment
- •Non-ill co-parent does not consent to join study
研究组 & 干预措施
Group II (educational material)
Patients receive carefully selected educational booklet that discuss ways to talk about their cancer with their child and a scripted phone call from a trained phone counselor on study.
干预措施: Group II Active Comparator (Behavioral)
Behavioral: Group 1: Educational counseling Group I (enhancing connections-palliative care program)
Patients receive the 5-session EC-PC program bi-weekly with a patient educator about ways to help them talk to and support their child.
干预措施: Group 1: Educational counseling intervention (Behavioral)
结局指标
主要结局
Treatment Efficacy Assessed by Parents' Mood-Center for Epidemiological Studies-Depression (CES-D)
时间窗: At 3 months post-baseline
Depressed mood will be measured by the 20-item Center for Epidemiological Studies- Depression Scale (CES-D) (Radloff, 1977). The CES-D Scale measures the recent occurrence of symptoms of depression. For each symptom, the respondent indicates the frequency with which that symptom has occurred during the past week, from "rarely or none of the time (less than 1 day)" to "most or all of the time (5-7 days)." This measure has been well- accepted in both ill and non-ill samples. Internal consistency in three samples from the general population has been reported by Radloff, 1977, and ranged between .84 to .85. Validity is well- established, including its link to the broader concept of "distress" in cancer-related research (Benazon \& Coyne, 2000). The internal consistency reliability is 0.85 or higher (Benazon \& Coyne, 2000). Total score ranges from 0-60. Higher scores denote worse outcome. Clinical cut off for distress is 16 or higher.
Treatment Efficacy Assessed by Parents' Anxiety [Spielberger State-Trait Anxiety (STAI, State Scale)]
时间窗: At 3 months post-baseline
State anxiety will be measured by the state component of the State-Trait Anxiety Inventory. This 20-item self-report questionnaire evaluates current feelings of apprehension, tension, nervousness, and worry. The respondent circles a response that best depicts their current feelings best. Response options range from \[1 - Not at all\] to \[5 - Very much so\]. Sample items include "I feel calm", I am tense." Higher scores denote greater anxiety. Internal consistency reliability is 0.90 or above in community and population samples \[Edwards and Clarke, 2004\]. Scale range: 20-80. Clinical cut off for distress is 40 or higher. Missing data imputation caused scores to be non-whole integers.
Parent's Confidence in Being Able to Talk With Her Child About the Child's Cancer-related Concerns (CASE Help Child Subscale)
时间窗: At 3 months post-baseline
Parenting Self-efficacy: Measured by the Help Child subscale of the parent-reported cancer Self-efficacy Scale (CASE). The Help Child subscale (9 items) measures the parent's confidence in being able to talk with her child about the child's cancer-related concerns; e.g., "I can assist my child to talk out his/her worries about my cancer." Structured response options range from "Not at all confident" (1) to "Very confident." The internal consistency reliability The internal consistency reliabilities in the EC seminal trial with parents with early stage cancer was 0.97. Higher scores denote better outcome. Range of scores: 0-90. There is no known clinical cutoff score on this measure.
Parents' Skills in Helping Their Child Cope and Manage the Toll of the Parents' Cancer (Connecting and Coping Subscale)
时间窗: At 3 months post-baseline
Parenting skills will be measured by the parent reported Parenting Skills Checklist: Connecting and Coping subscale developed by the study team and tested for reliability and validity in a 6-state randomized control trial (Lewis et al., 2015). The measure describes the observable interactional behaviors parents can use to assist their child disclose, discuss, and cope with the parent's cancer. The developmental-contextual model of parenting was the conceptual basis for the measure. An example item on the Connecting and Coping subscale includes, "I work with my child to help my child manage the child's stress related to my cancer." Range of subscale: 0-50. Higher scores reflect a better outcome. There is no clinical cut off score for parents' skills.
Child-Behavioral Emotional Functioning: Anxious/Depressed Score on the Child Behavioral Checklist (CBCL)
时间窗: At 3 months post-baseline
The child's behavioral-emotional adjustment will be measured by 3 subscales: the Anxious/Depressed scores, Internalizing Problems score, and Externalizing Problems scores, all part of the Child Behavior Checklist. See specific subscale scores, entered separately below. Response options for all subscales range from 0 to 2 from "Not True (as far as you know)" to "Somewhat or Sometimes True" to "Very True or Often True." Higher scores denote worse outcomes. Range of scores for Internalizing and Externalizing Problems is 34-100 and 50-100 for the Anxious/Depressed score. Internal consistency reliabilities were established as 0.90 for the Internalizing score and 0.94 for the Externalizing score. For the current study, the CBCL form for 6-18 year-olds and its computer software were used. The theoretical range of scores on the Anxious/Depressed score is 50-100. The theoretical range of the Internalizing and Externalizing problems subscales are both 34-100.
次要结局
未报告次要终点
研究者
Frances M. Lewis
Professor
University of Washington