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临床试验/NCT03526952
NCT03526952Unknown不适用

An Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With an Ostomy After Cancer

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Change in perceived self efficacy in coping with sexual and intimate changes from four different time points

研究概览

简要总结

This study investigates the feasibility and efficacy of an Internet-delivered intervention for the sexual and intimate re-adjustment of couples in which one partner is living with a temporary or permanent ostomy (e.g., colostomy, ileostomy, urostomy) following treatment for colorectal and/or bladder cancer. The two session intervention will be delivered via online videoconferencing and will focus on facilitating couples' communication around their sexual and intimate relationship. Exercises from sex therapy will be used to scaffold conversations about motivations for having sex, intimacy and sensual pleasure, and relational strengths for coping. The intervention aims to enhance couples' ability to cope with the changes in their sexual and intimate relationship. A group of couples receiving written educational material only will be used as a comparison group to measure change in sexual and intimate adjustment over time.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intervention Group

Experimental

Couples in this group will receive the Internet-Delivered Intervention for Sexual Re-Adjustment

干预措施: Internet-Delivered Intervention for Sexual Re-Adjustment (Other)

Educational Comparison Group

Active Comparator

Couples in this group will receive only written educational material about sexuality and intimacy with an ostomy.

干预措施: Written Educational Material (Other)

结局指标

主要结局

Change in perceived self efficacy in coping with sexual and intimate changes from four different time points

时间窗: This questionnaire will be completed by participants at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention)

Sexual Self-Efficacy: A 3-item questionnaire for assessing individual's perceived self-efficacy in coping with sexual and intimate change in the context of cancer. Respondents rate their level of confidence in coping with these changes on a scale of 0-100 (0 = cannot do at all, 100 = highly certain can do).

Change in communication about sex from four different time points

时间窗: This questionnaire will be completed by participants at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention)

Dyadic Sexual Communication Scale (DSC): The DSC scale is a 13-item scale that measures how respondents perceive the discussion of sexual matters with their partners. Items are rated on a 6-point Likert type scale (1 = Disagree Strongly, 6 = Agree Strongly).

Change in mutual identity from four different time points

时间窗: This questionnaire will be completed by participants at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention)

Inclusion of Other In Self Scale (IOSS): The IOSS is a one-item, visual measure of the degree to which one views one's partner as being part of one's self-concept. Respondents choose one of seven Venn-diagram type images that represent varying degrees of mutual identity. Higher scores represent greater degrees of self-other overlap in identity.

Change in relational identity or closeness from four different time points

时间窗: This questionnaire will be completed by participants at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention)

"We-ness" Questionnaire: A measure of the degree partner's perceive themselves more as being a unit ("we/us") than two separate identities ("I/me" or "you/him/her"), which encompassed an intertwined structure of affective, cognitive, and behavioural facets. The questionnaire includes 16-items about facets of couples' mutual identity and respondents use a 5-point Likert scale to rate the degree to which these facets contribute to their sense of mutual identity in their current relationship. Higher scores represent a greater sense of shared identity.

Change in sexual functioning from four different time points

时间窗: This questionnaire will be completed by participants at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention)

Sexual Functioning Questionnaire (SFQ): A measure sexual functioning developed specifically for cancer patients and their partners. This measure includes 22 scored items and nine subscales related to different areas of concern (i.e., Interest, Desire, Arousal, Satisfaction, Activity, Orgasm, Masturbation, Relationship, and Problems). For these subscales, higher scores represent better functioning. The optional 5-item Health Impact Scale assess the impact of cancer on the patient's sexual functioning and can be adapted for the partner. For the Health Impact subscale, higher scores represent greater impact.

次要结局

  • Change in relational adjustment from four different time points(This questionnaire will be completed by participants at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention))
  • Change in psychological adjustment (anxiety) from four different time points(This questionnaire will be completed by participants at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention))
  • Patients' change in adjustment to colorectal cancer from four different time points(This questionnaire will be completed by patients diagnosed with colorectal cancer at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention))
  • Patients' change in adjustment to bladder cancer from four different time points(This questionnaire will be completed by patients diagnosed with bladder cancer at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention))
  • Change in psychological adjustment (depression) from four different time points(This questionnaire will be completed by participants at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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