Effect of sex on psychological distress and fatigue over time in a prospective cohort of cancer survivors.

BACKGROUND: Studies indicate a higher level of distress in women than men with cancer, but whether this difference is retained over time is unknown. We studied the frequency and level of distress and fatigue during time according to gender in a cohort of cancer survivors. PATIENTS AND METHODS: In this prospective study, cancer survivors were invited to undergo a psychological session immediately before the medical visit. Distress was assessed by the distress thermometer, and fatigue was assessed by the ESAS-r scale. Patients underwent follow-up visits to assess changes over time. RESULTS: A total of 305 patients and 568 visits were performed with a median follow-up of 15.8 months. At baseline, females, young age, and breast cancer patients had significantly higher distress. However, there was an increase in distress of 0.29 points every 6 months in males (95% CI, 0.09-0.50) versus no change in females (0.03 points, 95% CI, - 0.09-0.15; p-interaction = 0.01). The different behavior of cancer distress during time according to gender was more evident in subjects aged 68 or older due to increasing physical problems in men (p-interaction = 0.005). There was no change in fatigue with time according to sex. CONCLUSIONS: Women, younger age, and breast cancer patients had increased cancer distress at the initial visit. However, women tend to stabilize during follow-up, whereas men tend to worsen their distress, especially because of physical and emotional problems, suggesting different coping capabilities. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov NCT05122052. IMPLICATIONS FOR CANCER SURVIVORS: Interventions aimed at improving recognition of emotions related to disease experience in male cancer survivors appear necessary.

Worry and risk perception of breast cancer in a prevention trial of low dose tamoxifen in midlife postmenopausal hormone users.

OBJECTIVE: There is increasing interest in combining postmenopausal hormone therapy (HT) and SERMs in midlife women. We previously showed that refusal to participate in a prevention trial of low dose tamoxifen in HT users was associated with higher worry about breast cancer. Given this counterintuitive finding, we studied which factors influenced worry and risk perception of breast cancer. METHODS: We assessed the relationships of breast cancer worry and risk perception with age, age at menopause, Gail risk, education, adherence to mammographic screening, BMI, smoking, physical activity, alcohol use, anxiety and depression in 457 midlife HT users who were eligible to participate in the trial. RESULTS: Women with menopause <48 years were more worried about breast cancer than women with menopause >52 years (OR = 5.0, 95% CI, 1.2-21.1). Worry was also associated with high absolute risk perception and former smoking. Factors associated with higher risk perception were age>60 years, at-risk life style, worry about breast cancer and depression. CONCLUSIONS: The inverse association between early menopause and worry about breast cancer is in contrast with the known protective effect of early menopause on breast cancer risk and seems to reflect a feeling of aging and disease vulnerability. Our findings indicate that worry about cancer has an affective construct which is independent of breast cancer biology but is engaged in health decision making. Increasing breast cancer risk awareness in subjects high in worry without a plan of emotional coping may therefore be counterproductive because of avoidant attitudes.

Evaluation of a screening programme for psychological distress in cancer survivors.

PURPOSE: This study is aimed at evaluating the feasibility of a screening procedure for psychological distress in cancer survivors. METHODS: Consecutive series of 339 cancer patients from three centres were requested to fill in two questionnaires measuring psychological distress (PDI) and social support (MOSS). Psychological intervention was offered to patients with significant degree of distress. RESULTS: Most patients accepted to be screened (72.0%; n = 244), and a subgroup (16.0%) showed high psychological distress. A higher ratio of distressed patients was observed among those with lower social support (P = 0.017). A significant (P < 0.01) negative correlation between psychological distress and social support was observed. A psychological intervention was offered to patients with high psychological distress, but only 15.6% completed it. CONCLUSIONS: Results from this study provide both some insights into the characteristics of psychological distress and some input on issues that may arise when implementing a screening procedure for psychological distress in cancer survivors. Further research is needed to assess both the clinical significance of distress and the most appropriate tools to carry out screening procedures within the target population.

Psychological and clinical factors implicated in decision making about a trial of low-dose tamoxifen in hormone replacement therapy users.

PURPOSE: To assess the sociodemographic, health-related, and psychological factors that influence the decision of women on hormone replacement therapy (HRT) to participate in a phase III trial of low-dose tamoxifen. PATIENTS AND METHODS: Clinical and psychological factors were assessed in 265 women who accepted and 192 women who refused to participate in a proposed trial. Health-related and sociodemographic factors included age, Gail risk, body mass index, education, current HRT use, regular mammographic screening, smoking habit, physical activity, alcohol use, concern about adverse effects, and physician recommendation. Psychological factors included breast cancer-related worry, absolute and comparative cancer risk perception, anxiety, and depression. RESULTS: The most frequent reasons for entry were willingness to participate in a research program (60%), the need/desire to receive frequent medical care (58%), and the desire to contribute to medical knowledge (44%); whereas reasons for refusal included fear of medication abuse (33%), concern about adverse effects (31%), and physician advice against enrollment (24%). In a logistic model, after adjusting for current HRT use, the trial participation was directly associated with satisfaction with clearly explained study objectives (odds ratio [OR] = 9.33; 95% CI, 4.04 to 21.55) and inversely associated with high breast cancer worry (OR = 0.15; 95% CI, 0.03 to 0.77) and age > or = 60 years (OR = 0.40; 95% CI, 0.22 to 0.73). CONCLUSION: Participation in a chemoprevention trial among HRT users is associated with a younger age, no breast cancer worry, and satisfaction with health care providers, suggesting a condition of psychological well-being as a promoting factor and emphasizing the importance of thorough counseling at study presentation.

Randomized dose-ranging trial of tamoxifen at low doses in hormone replacement therapy users.

PURPOSE: The combination of hormone replacement therapy (HRT) and low-dose tamoxifen may retain the benefits while reducing the risks of either agent. We assessed the optimal biologic dose and schedule of tamoxifen in HRT users using surrogate end point biomarkers and menopausal symptoms. SUBJECTS AND METHODS: Two hundred ten current or de novo HRT users were randomly assigned to one of the following four arms: tamoxifen 1 mg/day and placebo/week, placebo/day and tamoxifen 10 mg/week, tamoxifen 5 mg/day and placebo/week, or both placebos for 12 months. The primary end point was the change of plasma insulinlike growth factor 1 (IGF-I) through 12 months, and secondary end points were IGF-I/IGF binding protein-3 (IGFBP-3) ratio, fibrinogen, antithrombin III, C reactive protein, C-telopeptide, mammographic percent density, and endometrial thickness. Endometrial proliferation was assessed by Pipelle biopsy in superficial, deep glandular, and stromal compartments after 12 months. RESULTS: Compared with placebo, IGF-I declined in all tamoxifen arms (P = .005), with a greater change on 5 mg/day (P = .019 v 10 mg/week or 1 mg/day). Tamoxifen increased IGFBP-3 and lowered antithrombin-III, C reactive protein, and mammographic density, with greater effects of 5 mg/day. Tamoxifen increased endometrial thickness but not Ki-67 expression, which was lower on 5 mg/day among the three doses. Menopausal symptoms were not significantly worsened by tamoxifen. CONCLUSION: Doses of tamoxifen < or = 5 mg/day modulate favorably biomarkers of breast carcinogenesis and cardiovascular risk in HRT users with no increase of endometrial proliferation and menopausal symptoms. A dose of 5 mg/day was the most effective and has been selected for a phase III trial in HRT users.