scholarly journals Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer

2021 ◽  
Author(s):  
Christine Maheu ◽  
Sophie Lebel ◽  
Christine Courbasson ◽  
Monique Lefebvre ◽  
Mina Singh ◽  
...  

Background Clinically significant levels of fear of cancer recurrence (FCR) affect up to 49 % of cancer survivors and are more prevalent among women. FCR is associated with psychological distress, lower quality of life, and increased use of medical resources. Despite its prevalence, FCR is poorly addressed in clinical care. To address this problem, we first developed, and pilot tested a 6-week, 2 h, Cognitive-existential group intervention therapy that targeted FCR in survivors of breast or gynecological cancer. Following the positive outcome of the pilot, we are now testing this approach in a randomized clinical trial (RCT). Goal and hypotheses: This multicenter, prospective RCT aims to test the efficacy of the intervention. The study hypotheses are that, compared to a control group, cancer survivors participating in the intervention (1) will have less FCR, (2) will show more favorable outcomes on the following measures: cancer-specific distress, quality of life, illness uncertainty, intolerance of uncertainty, perceived risk of cancer recurrence, and coping skills. We further postulate that the between-group differences will persist three and 6 months post-intervention. Methods Sixteen groups of seven to nine women are being allocated to the intervention or the control group. The control group receives a 6-week, 2 h, structurally equivalent support group. We are recruiting 144 cancer survivors from four hospital sites in three Canadian cities. The sample size was based on the moderate pre/post-test changes found in our pilot study and adjusted to the drop-out rates. Measurements: The primary outcome, FCR, is measured by the Fear of Cancer Recurrence Inventory. Secondary outcomes measured include cancer-specific distress, perceived risk of cancer recurrence, illness uncertainty, intolerance of uncertainty, coping, and quality of life. We use reliable and recognized valid scales. Participants are to complete the questionnaire package at four times: before the first group session (baseline), immediately after the sixth session, and 3 and 6 months post-intervention. Analysis: In the descriptive analysis, comparison of group equivalent baseline variables, identification of confounding/intermediate variables and univariate analysis are planned. Each participant’s trajectory is calculated using Generalized Estimating Equation models to determine the time and group effects, after considering the correlation structures of the groups. An intent-to-treat analysis approach may be adopted. Discussion Our Fear of Recurrence Therapy (FORT) intervention has direct implications for clinical service development to improve the quality of life for patients with breast (BC) and gynecological cancer (GC). Based on our pilot data, we are confident that the FORT intervention can guide the development of effective psychosocial cancer survivorship interventions to reduce FCR and improve psychological functioning among women with BC or GC.

2021 ◽  
Author(s):  
Christine Maheu ◽  
Sophie Lebel ◽  
Christine Courbasson ◽  
Monique Lefebvre ◽  
Mina Singh ◽  
...  

Background Clinically significant levels of fear of cancer recurrence (FCR) affect up to 49 % of cancer survivors and are more prevalent among women. FCR is associated with psychological distress, lower quality of life, and increased use of medical resources. Despite its prevalence, FCR is poorly addressed in clinical care. To address this problem, we first developed, and pilot tested a 6-week, 2 h, Cognitive-existential group intervention therapy that targeted FCR in survivors of breast or gynecological cancer. Following the positive outcome of the pilot, we are now testing this approach in a randomized clinical trial (RCT). Goal and hypotheses: This multicenter, prospective RCT aims to test the efficacy of the intervention. The study hypotheses are that, compared to a control group, cancer survivors participating in the intervention (1) will have less FCR, (2) will show more favorable outcomes on the following measures: cancer-specific distress, quality of life, illness uncertainty, intolerance of uncertainty, perceived risk of cancer recurrence, and coping skills. We further postulate that the between-group differences will persist three and 6 months post-intervention. Methods Sixteen groups of seven to nine women are being allocated to the intervention or the control group. The control group receives a 6-week, 2 h, structurally equivalent support group. We are recruiting 144 cancer survivors from four hospital sites in three Canadian cities. The sample size was based on the moderate pre/post-test changes found in our pilot study and adjusted to the drop-out rates. Measurements: The primary outcome, FCR, is measured by the Fear of Cancer Recurrence Inventory. Secondary outcomes measured include cancer-specific distress, perceived risk of cancer recurrence, illness uncertainty, intolerance of uncertainty, coping, and quality of life. We use reliable and recognized valid scales. Participants are to complete the questionnaire package at four times: before the first group session (baseline), immediately after the sixth session, and 3 and 6 months post-intervention. Analysis: In the descriptive analysis, comparison of group equivalent baseline variables, identification of confounding/intermediate variables and univariate analysis are planned. Each participant’s trajectory is calculated using Generalized Estimating Equation models to determine the time and group effects, after considering the correlation structures of the groups. An intent-to-treat analysis approach may be adopted. Discussion Our Fear of Recurrence Therapy (FORT) intervention has direct implications for clinical service development to improve the quality of life for patients with breast (BC) and gynecological cancer (GC). Based on our pilot data, we are confident that the FORT intervention can guide the development of effective psychosocial cancer survivorship interventions to reduce FCR and improve psychological functioning among women with BC or GC.


2018 ◽  
Vol 17 (4) ◽  
pp. 1183-1194 ◽  
Author(s):  
Yi-Hua Lee ◽  
Gi-Ming Lai ◽  
De-Chih Lee ◽  
Lee-Jang Tsai Lai ◽  
Yuan-Ping Chang

Objectives: Cancer-related fatigue and fear of recurrence (FOR) are the most common symptoms in cancer survivors and severely affect quality of life (QOL). This study aims to promote and evaluate the effectiveness of physical and psychological rehabilitation activities for cancer survivors. Methods: A longitudinal study with an interventional research design was conducted. A total of 80 participants were randomly assigned to experimental groups E1 (Qigong exercise [QE]) or E2 (stress management [SM]) or the control group. The E1 and E2 groups received QE and SM, respectively, as interventions once a week for 12 weeks, and effects were assessed. Cancer-related fatigue, FOR, QOL, and heart rate variability (HRV) were evaluated at baseline (T0), after 12 weeks (T1), and at the 3-month follow-up (T2). Results: QE and SM effectively strengthened the physical and psychological functions of cancer survivors at the T1 phase. Although differences in FOR and QOL were not statistically significant, the scores were decreased and increased, respectively. Although the effects during the T2 phase were not as significant as those during T1, the score progress was maintained. The effects on HRV were significantly different among the E1, E2, and control groups at T1, which shows that the performance of both experimental groups was better than that of the control group. Conclusions: Physical and psychological rehabilitation activities should be practiced periodically and should be led by professional staff. Long-term educational resources and care should also be provided. HRV can be used to efficiently monitor the status of the mind-body balance and is a more suitable index than questionnaires for physical and psychological function evaluation in cancer survivors.


2019 ◽  
Vol 41 (10) ◽  
pp. 1385-1406 ◽  
Author(s):  
Anne M. Reb ◽  
Diane G. Cope

Gynecologic cancer survivors experience significant distress that can impact quality of life (QOL). Optimal survivorship care requires an understanding of the survivor’s QOL and supportive care needs. The purpose of this study was to describe the QOL and needs of gynecologic cancer survivors. Women with an initial diagnosis of gynecologic cancer within 7 months of completing primary treatment ( N = 34) completed the QOL-Cancer Survivor tool and the Cancer Survivors’ Unmet Needs Survey. Fear of cancer recurrence was a repetitive theme for both tools. The lowest ranking QOL items were distress from diagnosis and treatment, family distress, and uncertainty about the future. Commonly reported needs included help to reduce stress, manage side effects, cope with fears of cancer recurrence, and gain reassurance that providers were communicating, and providing the very best medical care. Appreciating QOL and needs can facilitate the development of support services specifically tailored to gynecologic survivors.


2018 ◽  
Vol 24 (2) ◽  
pp. 12-19 ◽  
Author(s):  
Tri Wijayanti ◽  
Yati Afiyanti ◽  
Hayuni Rahmah ◽  
Ariesta Milanti

Background: Fear of cancer recurrence is a long-term psychological problem of the cancer survivors regardless of the type of cancer. A growing number of studies had addressed fear of cancer recurrence, yet they are largely focused on the breast cancer survivors of the western world countries. This study investigates the fear of cancer recurrence and its relations to social support in Indonesian gynecological cancer survivors. Methods: Gynecological cancer survivors (n = 153) in Samarinda, East Kalimantan, Indonesia completed Fear of Cancer Recurrence Inventory, Interpersonal Support Evaluation List, socio-demographic and clinically-related characteristics questionnaires. Pearson r correlation tests, t-tests, and ANOVAs were used to identify the relationships between variables, and linear regression to determine to what extent the social support may predict the survivors? fear of recurrence. Results: Indonesian gynecological cancer survivors with higher social support were more likely to experience lower levels of fear of cancer recurrence. Whereas, having a family history of cancer was an important predictor of fear of cancer recurrence levels. Conclusion: Social support plays an essential role in predicting fear of cancer recurrence among Indonesian gynecological cancer survivors.


2019 ◽  
Author(s):  
Gek Phin Chua ◽  
Quan Sing Ng ◽  
Hiang Khoon Tan ◽  
Whee Sze Ong

Abstract Background The aim of this study is to determine the main concerns of survivors at various stages of the cancer survivorship of the cancer survivorship trajectory and to assess whether these concerns have any effect on their quality of life (QOL). The overall goal was to use the insights from the study to guide practice on patient care. Methods A cross-sectional survey of 1107 cancer survivors diagnosed with colorectal, breast, lung, gynaecological, prostate or liver cancers from a cancer centre in Singapore. Eligible patients self-completed a questionnaire adapted from the Mayo Clinic Cancer Centre’s Cancer Survivors Survey of Needs. Results The top 5 concerns among all survivors were cancer treatment and recurrence risk (51%), followed by long-term treatment effects (49%), fear of recurrence (47%), financial concerns (37%) and fatigue (37%). Cancer treatment and recurrence risk, long-term treatment effects and fear of recurrence were amongst the top concerns across the survivorship trajectory. Mean QOL was 7.3 on a scale of 0 – 10. Completed treatment patients had higher QOL score than the newly diagnosed and on treatment patients and the patients dealing with recurrence or second cancer patients. Predictors for QOL included the economic status and housing type of patients and whether patients were concerned with pain and fatigue Conclusion This study confirms that cancer survivors in Singapore face multiple challenges and had various concerns at various stages of cancer survivorship, some of which negatively affect their QOL It is critical to design patient care delivery that appropriately address the various concerns of cancer survivors in order for them to cope and improve their QOL.


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