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Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners

Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners: Evaluation of Effectiveness in Adjustment of Sexuality and Intimacy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03936400
Enrollment
120
Registered
2019-05-03
Start date
2017-04-15
Completion date
2019-08-20
Last updated
2019-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

cancer, females, partners

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALCouple-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)

Sponsors

Landspitali University Hospital
CollaboratorOTHER
Erla Kolbrún Svavarsdóttir
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Single females * Do not read or write nor speak Icelandic

Design outcomes

Primary

MeasureTime frameDescription
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in experimental group (T1).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).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).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).T1 (at baseline).This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) pre-intervention in control group (T2).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).T3 (post-intervention, 1-2 weeks from T2).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).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) at baseline in experimental group (T1).T1 (at baseline).This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T2).T2 (1-2 weeks after baseline).This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T3).T3 (3 months after 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).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).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).T3 (post-intervention, 1-2 weeks from T2).This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T4).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) at baseline in experimental group (T1).T1 ( at 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 experimental group (T2).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).T3 (3 months after baseline).The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in control group (T1).T1 (at baseline).The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) pre-intervention in control group (T2).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).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).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).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).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).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.
The Illness Intrusiveness Rating Scale (IIRS) at baseline in control group (T1).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).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.
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T3).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.
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T4).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.

Countries

Iceland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026