An interventional study of Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy in Cancer, sponsored by Erla Kolbrún Svavarsdóttir. Completed at 1 site in Iceland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-22.
Sponsored by Erla Kolbrún Svavarsdóttir · Not applicable, Interventional, and Treatment
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.
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.
This is the only study on the registry with Erla Kolbrún Svavarsdóttir as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental group receiving a couple-based intervention
Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy
A control group that receives same but delayed couple-based intervention
Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy
Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in experimental group (T1).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Time frame: T1 ( at baseline).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T2).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Time frame: T2 (1-2 weeks after baseline).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T3).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Time frame: T3 (3 months after baseline).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in control group (T1).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Time frame: T1 (at baseline).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) pre-intervention in control group (T2).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Time frame: T2 (wait-pre-intervention, 1 month after baseline).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T3).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Time frame: T3 (post-intervention, 1-2 weeks from T2).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T4).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Time frame: T4 (post-intervention, 3 months from T3).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in experimental group (T1).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Time frame: T1 (at baseline).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T2).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Time frame: T2 (1-2 weeks after baseline).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T3).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Time frame: T3 (3 months after baseline).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in control group (T1).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Time frame: T1 (at baseline).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) pre-intervention in control group (T2).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Time frame: T2 (wait-pre-intervention, 1 month after baseline).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T3).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Time frame: T3 (post-intervention, 1-2 weeks from T2).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T4).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Time frame: T4 (post-intervention, 3 months from T3).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in experimental group (T1).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
Time frame: T1 ( at baseline).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T2).
he instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
Time frame: T2 (1-2 weeks after baseline).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T3).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
Time frame: T3 (3 months after baseline).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in control group (T1).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
Time frame: T1 (at baseline).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) pre-intervention in control group (T2).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
Time frame: T2 (wait-pre-intervention, 1 month after baseline).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T3).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
Time frame: T3 (post-intervention, 1-2 weeks from T2).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T4).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
Time frame: T4 (post-intervention, 3 months from T3).
The Illness Intrusiveness Rating Scale (IIRS) at baseline in experimental group (T1).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
Time frame: T1 ( at baseline).
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T2).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
Time frame: T2 (1-2 weeks after baseline).
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T3).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
Time frame: T3 (3 months after baseline).
The Illness Intrusiveness Rating Scale (IIRS) at baseline in control group (T1).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
Time frame: T1 (at baseline).
The Illness Intrusiveness Rating Scale (IIRS) pre-intervention in control group (T2).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
Time frame: T2 (wait-pre-intervention, 1 month after baseline).
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T3).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
Time frame: T3 (post-intervention, 1-2 weeks from T2).
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T4).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
Time frame: T4 (post-intervention, 3 months from T3).
Plan to share: No
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