Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners: Evaluation of Effectiveness in Adjustment of Sexuality and Intimacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in control group (T1).
研究概览
简要总结
The main purpose of the doctoral study is to better understand the experience of cancer diagnosis and treatment in how it effects sexuality and intimacy of the female cancer patient and her partner.
详细描述
With this increased understanding, an intervention, comprised of therapeutic interventions with the couple, will be conducted and assessed on how it affects the couple's general well-being and recovery of the sexual and intimate relationship.
The intervention consists of three therapeutic conversations, based on the Illness Beliefs model in family nursing, and an optional web-based evidence based information. The aim of the intervention is to support the facilitating beliefs of the couple in adapting to changes in intimacy and identify constraining beliefs. In the first session an emphasis is on creating an optimal context for changing beliefs by building good therapeutic relationship and to invite them to share their experience, giving them the opportunity to voice their own concerns and reflect on how their situation effects their intimate relationship. In the second session, the couple take a closer look at what they themselves deem important in adjusting to changes in their intimate relationship. In both sessions information about the possible sexual side effects of treatment will be offered as needed and evidence based, optional web-based information on practical solutions will be provided. In the booster-session, the couple will assess how they have been adjusting in their intimate relationship and any positive changes that have occurred will be accentuated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All females, 18 yrs and older, diagnosed with cancer (all types) and their partners
- •Have began cancer treatment (surgical treatment, chemotherapy, radiation) - Are in a couple relationship
- •Live in Iceland and are able to travel to site of intervention
- •Speak and write Icelandic
排除标准
- •Single females
- •Do not read or write nor speak Icelandic
结局指标
主要结局
ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in control group (T1).
时间窗: T1 (at baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T3).
时间窗: T3 (post-intervention, 1-2 weeks from T2).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in experimental group (T1).
时间窗: T1 ( at baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T2).
时间窗: T2 (1-2 weeks after baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T3).
时间窗: T3 (3 months after baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in control group (T1).
时间窗: T1 (at baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T4).
时间窗: T4 (post-intervention, 3 months from T3).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T2).
时间窗: T2 (1-2 weeks after baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) pre-intervention in control group (T2).
时间窗: T2 (wait-pre-intervention, 1 month after baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T3).
时间窗: T3 (post-intervention, 1-2 weeks from T2).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T3).
时间窗: T3 (3 months after baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T4).
时间窗: T4 (post-intervention, 3 months from T3).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
ICE-Beliefs questionnaire for couples (ICE-COUPLE) pre-intervention in control group (T2).
时间窗: T2 (wait-pre-intervention, 1 month after baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T3).
时间窗: T3 (post-intervention, 1-2 weeks from T2).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T4).
时间窗: T4 (post-intervention, 3 months from T3).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
The Illness Intrusiveness Rating Scale (IIRS) at baseline in experimental group (T1).
时间窗: T1 ( at baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T2).
时间窗: T2 (1-2 weeks after baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T3).
时间窗: T3 (3 months after baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in experimental group (T1).
时间窗: T1 (at baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in control group (T1).
时间窗: T1 (at baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) pre-intervention in control group (T2).
时间窗: T2 (wait-pre-intervention, 1 month after baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T3).
时间窗: T3 (post-intervention, 1-2 weeks from T2).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T2).
时间窗: T2 (1-2 weeks after baseline).
he instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T3).
时间窗: T3 (3 months after baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T4).
时间窗: T4 (post-intervention, 3 months from T3).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
The Illness Intrusiveness Rating Scale (IIRS) at baseline in control group (T1).
时间窗: T1 (at baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
The Illness Intrusiveness Rating Scale (IIRS) pre-intervention in control group (T2).
时间窗: T2 (wait-pre-intervention, 1 month after baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in experimental group (T1).
时间窗: T1 ( at baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
次要结局
未报告次要终点
研究者
Erla Kolbrún Svavarsdóttir
Professor
University of Iceland