Efficacy of Fex-Can Fertility, a web-based psychoeducational intervention for young adults with fertility-related distress following cancer: a randomized controlled trial. (Preprint)

Author:

Micaux ClaireORCID,Wiklander MariaORCID,Eriksson Lars E.,Wettergren LenaORCID,Lampic ClaudiaORCID

Abstract

BACKGROUND

Threatened fertility following a cancer diagnosis in reproductive age may severely impact on the emotional and psychosocial wellbeing in survivorship. Effective web-based interventions for fertility-related distress have so far been lacking.

OBJECTIVE

This study aimed to test if the Fertility and Sexuality following Cancer (Fex-Can) intervention was superior to standard care in reducing fertility-related distress and related psychosocial outcomes in young adults with cancer.

METHODS

This Randomized Controlled Trial (RCT) evaluated a 12-week web-based, automated self-help intervention for fertility-related distress following cancer, The Fex-Can Fertility. Individuals were identified via Swedish national quality registries and those reporting fertility-related distress 1.5 years post-diagnosis were invited. A total of 100 women and 24 men (age 19-40) answered self-administered surveys at baseline (T0), directly post-intervention (T1) and three months later (T2). Main outcome was fertility-related distress measured with the six-dimension Reproductive Concerns After Cancer (RCAC) scale. Secondary outcomes were health-related quality of life (EORTC-QLQ-C30), emotional distress (HADS), fertility-related knowledge and fertility self-efficacy. In addition, the intervention group (IG) reported their self-perceived change in problems related to fertility after cancer (T1). T-tests and linear mixed models including intention-to-treat and subgroup analyses were performed to compare the effects of the intervention with standard care.

RESULTS

Although 60% (30 participants) in the IG stated their concerns about fertility were fewer post-intervention, there were few statistically significant group differences in the main outcome (RCAC) at T1 and T2. Compared to controls, the IG rated lower distress concerning the dimension Child’s health at T2 (p=.003, ES=0.64). This difference was maintained when adding group x time interaction (intention-to-treat; p=.003, ES=0.58). The IG also perceived better cancer-related fertility knowledge at T1/T2 (p=.05, ES=0.35/p=.01, ES=0.42) than did the control group. Subgroup analyses based on dose/adherence and baseline RCAC scores did not substantially alter the results. Overall utilization of the web-based program was low.

CONCLUSIONS

The Fex-Can intervention had small to moderate positive effects on cancer-related fertility knowledge and distress related to child’s health. The lack of group differences in other dimensions of fertility distress and related secondary outcomes contrasted with reports on self-perceived improvement post-intervention. The Fex-Can Fertility program may be a useful complement to routine psychosocial support in the clinical care of young women and men with cancer.

CLINICALTRIAL

ISRCTN36621459. Registered 25 January 2016.

Publisher

JMIR Publications Inc.

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