跳至主要内容
临床试验/NCT02453295
NCT02453295Unknown不适用

Testing an Intervention to Foster Hope for Cancer Survivors With Lymphedema

University of Ottawa0 个研究点目标入组 60 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Adjustment to illness as per the Meaning of Illness (MIQ) tracked at 5 timepoints over 16 weeks

研究概览

简要总结

The specific objectives and research questions of the proposed study are:

  1. a. Administer a group rehabilitation intervention to address loss and foster hope in 30 participants with upper and lower limb SLC --15 in an intervention group (IG), 15 in a control group (CG) at each of two research sites (Montreal, QC and Saint John, NB) for a total sample size of 60. Data about its impact will be collected by means of audiorecording 8 intervention workshops at each site and administering questionnaires (multiple timepoints).

b. Test the intervention - Main hypothesis: The intervention group will show improvements in psychosocial well-being. 2. Assess feasibility (e.g., review our accrual strategies, randomization of participants, and data collection) via the completion of process logs.

详细描述

This mixed methods pilot study builds on completed interviews with 13 participants in 2012 (Study 1, S1) and delivery of a community-based intervention to 13 participants in 2013 (over 2 days; Study 2, S2). The proposed research draws on these two studies, S1 (REB#H-05-12-04) and S2 (REB#H-05-12-04B), both of which were approved by the uOttawa REB. S2 included the same intervention as the one proposed herein, but in a compressed format. It was delivered in Ottawa, with positive feedback received from all 13 participants.

Administration of the intervention will draw upon the team members' expertise (Hamilton, Hack) with interventions for people with cancer, a program of research in hope interventions, and Thomas' work with women with breast cancer related LE as well as S1 and S2. The intervention will follow a group-based workshop format. The intervention workshops will be offered weekly over 8 sessions (2 hours per session, one per week). After an introductory workshop, the second session will involve viewing the video, created by PI Thomas interviewing men and women who have lymphedema and group discussion of its themes, based on the principles of video modelling (e.g., how do participants' experiences, hope strategies compare?). This is an approach used successfully in other areas of research with marginalized peoples.

Our program will follow Herth's theoretical foundations and goals (e.g., identifying support systems, developing plans to maintain hope in the future) along with established approaches to supportive care in chronic illnesses and LE international best practice guidelines. Briefly, workshops include modules addressing the building of a supportive community; orienting to hope and identifying threats to hope/coping; positive self-talk and affirmations; creative practices for exploring experiences and hope; and identifying and mobilizing resources. The modules also incorporate the completion and discussion of creative projects (e.g., writing exercises), mini-lectures by rehabilitation professionals, and SLC resources. All of these components were reviewed positively (satisfactory or above) by the majority of participants in S2. All activities are drawn from Herth's intervention, prior research, and the success of S2. This content was approved by the uOttawa REB, as noted previously. Four questionnaires administered to the IG/CG will be used to assess the potential impact of the intervention. Please see Study Protocol for summary of data collection.

SUMMARY OF QUESTIONNAIRES

  1. The Meaning of Illness Questionnaire, (MIQ) Factor II and IV: Factor II addresses loss, stress, and function. Factor IV addresses hope as well as positive attitude and motivation. These 2 factors will be used to screen participants prior to the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Adjustment to illness as per the Meaning of Illness (MIQ) tracked at 5 timepoints over 16 weeks

时间窗: T0 - beginning (3 days prior to 1st workshop); T1 - midpoint; T2 - endpoint (3 days following final workshop); T3 - 4 weeks post-intervention; T4 - 8 weeks post-intervention

Factor II and IV: Factor II addresses loss, stress, and function. Factor IV addresses hope as well as positive attitude and motivation. These 2 factors will be used to screen participants prior to the study. The full version of the MIQ will be administered at all timepoints once the study begins, along with the other questionnaires.

Quality of life as per the Short Form 12, (SF-12) tracked at 5 timepoints over 16 weeks

时间窗: T0 - beginning (3 days prior to 1st workshop); T1 - midpoint; T2 - endpoint (3 days following final workshop); T3 - 4 weeks post-intervention; T4 - 8 weeks post-intervention

Quality of Life (QOL) scale that measures seven concepts, including physical functioning, role limitations due to health problems, and social functioning. It is a shorter but valid alternative to the SF 36 and includes psychological aspects of illness (e.g., feeling energetic) not addressed by other instruments but relevant to S1 and S2 participants

Level of hope as per the Herth Hope Index (HHI) tracked at 5 timepoints over 16 weeks

时间窗: T0 - beginning (3 days prior to 1st workshop); T1 - midpoint; T2 - endpoint (3 days following final workshop); T3 - 4 weeks post-intervention; T4 - 8 weeks post-intervention

12-item (4 point) Likert scale that delineates 3 factors of hope: a) temporality \& future, b) positive readiness \& expectancy, and c) interconnectedness.32 Summative scores range from 12-48, with a higher score denoting greater hope. The HHI was piloted in and deemed to be acceptable in S2. Participants encountered few difficulties with completion.

Impact of lymphedema as per the Lymphedema Quality of Life (LYMQOL) tracked at 5 timepoints over 16 weeks

时间窗: T0 - beginning (3 days prior to 1st workshop); T1 - midpoint; T2 - endpoint (3 days following final workshop); T3 - 4 weeks post-intervention; T4 - 8 weeks post-intervention

Validated measure for the impact of UL/LL LE. The instrument includes 28 UL items and 27 LL items for LE. Importantly, questions address physical LE symptoms, emotional impact, and activities of daily living.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roanne Thomas

Canada Research Chair/Professor

University of Ottawa

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